0001493152-20-023253.txt : 20201210 0001493152-20-023253.hdr.sgml : 20201210 20201210150954 ACCESSION NUMBER: 0001493152-20-023253 CONFORMED SUBMISSION TYPE: F-1/A PUBLIC DOCUMENT COUNT: 35 FILED AS OF DATE: 20201210 DATE AS OF CHANGE: 20201210 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BriaCell Therapeutics Corp. CENTRAL INDEX KEY: 0001610820 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 0731 FILING VALUES: FORM TYPE: F-1/A SEC ACT: 1933 Act SEC FILE NUMBER: 333-234292 FILM NUMBER: 201380416 BUSINESS ADDRESS: STREET 1: 3RD FLOOR, BELLEVUE CENTRE, 235-15TH STR CITY: WEST VANCOUVER STATE: A1 ZIP: V7T 2X1 BUSINESS PHONE: (604) 921-1810 MAIL ADDRESS: STREET 1: 3RD FLOOR, BELLEVUE CENTRE, 235-15TH STR CITY: WEST VANCOUVER STATE: A1 ZIP: V7T 2X1 FORMER COMPANY: FORMER CONFORMED NAME: Ansell Capital Corp. DATE OF NAME CHANGE: 20140613 F-1/A 1 formf1a.htm

 

As filed with the Securities and Exchange Commission on December 10, 2020

 

Registration No. 333-234292

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

Amendment No. 11 to

FORM F-1

 

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

 

 

 

BRIACELL THERAPEUTICS CORP.

(Exact name of Registrant as specified in its charter)

 

British Columbia   2834   47-1099599
(State or other jurisdiction of   (Primary Standard Industrial   (I.R.S. Employer
incorporation or organization)   Classification Code Number)   Identification Number)

 

Suite 300 – 235 15th Street

West Vancouver, BC V7T 2X1

Telephone: (604) 921-1810

(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

 

Paracorp Incorporated

2804 Gateway Oaks Drive #100,

Sacramento, CA 95833

Telephone: (888) 280-6563

(Name, address, including zip code, and telephone number, including area code, of agent of service)

 

Copies to:

 

Gregory Sichenzia, Esq.

Avital Perlman, Esq.

Sichenzia Ross Ference LLP

1185 Avenue of Americas

37th Floor

New York, NY 10036

Telephone: (212) 930-9700

Facsimile: (212) 930-9725

 

Aaron Sonshine

Bennett Jones LLP

3400 One First Canadian Place

P.O. Box 130, Toronto, ON

M5X 1A4

Telephone: (416) 777-6448

Facsimile: (416) 863-1716

 

Virgil Z. Hlus

Clark Wilson LLP

Suite 900-885 West Georgia Street

Vancouver, BC,V6C 3H1

Telephone: (604) 687-5700

Facsimile: (604) 687-6314

 

Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement becomes effective.

 

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. [X]

 

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [  ]

 

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [  ]

 

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [  ]

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933. Emerging growth company [X]

 

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 7(a)(2)(B) of the Securities Act. [  ]

 

† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

 

CALCULATION OF REGISTRATION FEE

 

   

Proposed Maximum
Aggregate Offering Price(1)

   

Amount of
Registration Fee

 
Common Units (3)   $

16,915,858.88

(2)(4)(5)   $ 1,845.52  
Common shares, no par value, included in the Common Units       (6)        
Warrants included in the Common Units (7)       (6)        
Pre-funded Units (8)       (5)(9)        
Pre-funded Warrants included in the Pre-funded Units (10)       (11)        
Warrants included in the Pre-funded Units (7)       (11)        
Common shares underlying the Pre-funded warrants included in the Pre-funded Units                
Common shares underlying the warrants included in the Common Units and the Pre-funded Units   $

21,144,823.60

(2)   $

2,306.90

 
Warrants to be issued to the Underwriters       (12)        
Common shares underlying warrants to be issued to the Underwriters   $

1,057,241.18

(2)(13)   $ 115.35  
Common shares offered by the Selling Shareholder   $

190,500

(14)   $

20.79

 
Total   $

39,308,423.66

    $

4,288.56

(15)

 

  1) Pursuant to Rule 416, the securities being registered hereunder include such indeterminate number of additional securities as may be issued after the date hereof as a result of stock splits, stock dividends or similar transactions.
     
  2) Calculated pursuant to Rule 457(o) on the basis of the maximum aggregate offering price of all of the securities to be registered.
     
  3) Each Common Unit consists of one common share and one warrant, each whole warrant exercisable for one common share.
     
  4) Includes common shares and/or warrants representing 15% of the number of common shares and warrants included in the Common Units offered to the public that the underwriters have the option to purchase to cover over-allotments, if any.
     
  5) The proposed maximum aggregate offering price of Common Units proposed to be sold in the offering will be reduced on a dollar-for-dollar basis based on the offering price of any Pre-funded Units offered and sold in the offering, and the proposed maximum aggregate offering price of the Pre-funded Units to be sold in the offering will be reduced on a dollar-for-dollar basis based on the offering price of any Common Units sold in the offering. Accordingly, the proposed maximum aggregate offering price of the Common Units and Pre-funded Units (including the common shares issuable upon exercise of the Pre-funded warrants included in the Pre-funded Units), if any, is $16,915,858.88.

     
  6) Included in the price of the Common Units. No separate registration fee required pursuant to Rule 457(g) under the Securities Act of 1933, as amended.
     
  7) The warrants are exercisable at a price per common share equal to 125% of the Common Unit offering price.
     
  8) Each Pre-funded Unit consists of one Pre-funded warrant to purchase one common share and one warrant to purchase one common share.
     
  9) Includes Pre-funded warrants and/or warrants representing 15% of the number of Pre-funded warrants and warrants included in the Pre-funded Units offered to the public that the underwriters have the option to purchase to cover over-allotments, if any
     
  10) The Pre-funded warrants are exercisable at an exercise price of $0.01 per share.
     
  11) Included in the price of the Pre-funded Units. No separate registration fee required pursuant to Rule 457(g) under the Securities Act of 1933, as amended.
     
  12) No fee pursuant to Rule 457(g) under the Securities Act of 1933, as amended
     
  13) Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(g) under the Securities Act of 1933, as amended. We have agreed to issue to the underwriters warrants to purchase a number of common shares equal to 5% of the aggregate number of Common Units and Pre-funded Units sold in the offering (including the Common Units and Pre-funded Units issuable upon exercise of the over-allotment option). The warrants are exercisable at a per share exercise price equal to 125% of the per Common Unit public offering price for five years after the effective date of this registration statement.
     
  14)

Estimated in accordance with Rule 457(c) under the Securities Act of 1933, as amended, solely for the purpose of calculating the registration fee, based on the average of the high and low prices of the registrant’s common shares, as reported on the OTCQB on December 9, 2020.

     
  15) Previously paid.

 

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

 

 
 

 

EXPLANATORY NOTE

 

This Registration Statement contains two forms of prospectuses: one to be used in connection with the initial public offering of up to 3,268,765 common units and pre-funded units through the underwriters named on the cover page of this prospectus (the “IPO Prospectus”) and one to be used in connection with the potential resale by a selling shareholder of up to 50,000 common shares (the “Selling Shareholder Prospectus”). The IPO Prospectus and the Selling Shareholder Prospectus will be identical in all respects except for the alternate pages for the Selling Shareholder Prospectus included herein which are labeled “Alternate Pages for Selling Shareholder Prospectus.”

 

The Selling Shareholder Prospectus is substantively identical to the IPO Prospectus, except for the following principal points:

 

  they contain different outside and inside front covers;
     
  they contain different Offering sections in the Prospectus Summary section;
     
  they contain different Use of Proceeds sections;
     
  the Capitalization section is deleted from the Selling Shareholder Prospectus;
     
  the Dilution section is deleted from the Selling Shareholder Prospectus;
     
  a Selling shareholder section is included in the Selling Shareholder Prospectus;
     
  the Underwriting section from the IPO Prospectus is deleted from the Selling Shareholder Prospectus and a Plan of Distribution is inserted in its place; and
     
  the Legal Matters section in the Selling Shareholder Prospectus deletes the reference to counsel for the underwriters.

 

We have included in this Registration Statement, after the financial statements, a set of alternate pages to reflect the foregoing differences of the Selling Shareholder Prospectus as compared to the IPO Prospectus.

 

While the selling shareholder has expressed an intent not to sell the common shares registered pursuant to the Selling Shareholder Prospectus prior to the closing of or concurrently with the public offering, the sales of our common shares registered in the IPO Prospectus and the Selling Shareholder Prospectus may result in two offerings taking place sequentially or concurrently, which could affect the price and liquidity of, and demand for, our common shares. This risk and other risks are included in “Risk Factors” beginning on page 19 of the IPO Prospectus.

 

 
 

 

The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

 

PRELIMINARY PROSPECTUS SUBJECT TO COMPLETION DATED DECEMBER 10, 2020

 

Up to 3,268,765 Common Units, Each Consisting of a Common Share and a Warrant to Purchase One Common Share

 

Up to 3,268,765 Pre-funded Units, Each Consisting of a Pre-funded Warrant to Purchase One Common Share and a Warrant to Purchase One Common Share

 

 

 

BriaCell Therapeutics Corp.

 

 

 

We are offering up to 3,268,765 common units (each, a “Common Unit”), each Common Unit consisting of one common share, no par value per share, and one warrant (each a “Warrant”), in a firm commitment underwritten offering at an assumed public offering price of US$4.25 per Common Unit, the lower end of our estimated price range of US$4.25 and US$4.50 per Common Unit. The actual offering price per Common Unit will fall within this range. Each Warrant will entitle the holder to purchase one common share at an exercise price of US$___, equal to 125% of the public offering price of one Common Unit, and expire five years from the date of issuance.

 

We are also offering to those purchasers, if any, whose purchase of Common Units in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common shares immediately following the consummation of this offering, the opportunity to purchase, if the purchaser so chooses, pre-funded units (each a “Pre-funded Unit”) in lieu of Common Units that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common shares. We are offering a maximum of Pre-funded Units. Each Pre-funded Unit will consist of a pre-funded warrant to purchase one common share at an exercise price of US$0.01 per share (each a “Pre-funded Warrant”) and a Warrant. The purchase price of each Pre-funded Unit is equal to the price per Common Unit being sold to the public in this offering, minus US$0.01. The Pre-funded Warrants will be immediately exercisable and may be exercised at any time until all of the Pre-funded Warrants are exercised in full. We are offering the Pre-funded Units at an assumed public offering price of US$4.24 per Pre-funded Unit, the lower end of our estimated price range of US$4.24 and US$4.49 per Pre-funded Unit. The actual offering price per Pre-funded Unit will fall within this range.

 

For each Pre-funded Unit we sell, the number of Common Units we are offering will be decreased on a one-for-one basis. Common Units and Pre-funded Units will not be certificated. The common shares or Pre-funded Warrants, as the case may be, and the Warrants included in the Common Units or the Pre-funded Units, can only be purchased together in this offering, but the securities contained in the Common Units or Pre-funded Units are immediately separable and will be issued separately.

 

The offering also includes the common shares issuable from time to time upon exercise of the Pre-Funded Warrants and Warrants.

 

In addition, we have registered an aggregate of 50,000 common shares for resale by a certain shareholder by means of separate prospectus (the “Selling Shareholder Prospectus”). While the selling shareholder has expressed an intent not to sell the common shares registered pursuant to the Selling Shareholder Prospectus prior to the closing of or concurrently with the public offering, the sales of our securities registered in the IPO Prospectus and the Selling Shareholder Prospectus may result in two offerings taking place sequentially or concurrently, which could affect the price and liquidity of, and demand for, our common shares.

 

Our common shares are currently quoted on the U.S. OTCQB marketplace of OTC Markets Group, or OTCQB, under the symbol “BCTXF”, on the TSX Venture Exchange, or TSXV, under the symbol “BCT” and on the Frankfurt Stock Exchange under the Symbol “8BTA”. We are in the process of applying to list our common shares and our Warrants on the Nasdaq Capital Market under the symbols “BCTX” and “BCTXW”, respectively. No assurance can be given that our application will be approved. Nasdaq has informed us that it will not approve our application if the per Common Unit offering price in this offering is less than US$4.25. If Nasdaq does not approve the listing of our common shares and Warrants, we will not proceed with this offering.

 

On January 2, 2020, we implemented a 1-for-300 consolidation, or reverse split, of our issued and outstanding common shares prior to the date that we price this offering. Except where otherwise indicated, all share and per share data in this prospectus have been retroactively restated to reflect the reverse stock split.

 

On December 9, 2020, the closing price of our common shares was US$3.81 per share, as reported on the OTCQB. We have assumed a public offering price of US$4.25 per Common Unit, the low end of our estimated price range of US$4.25 and US$4.50 per Common Unit. The actual offering price per Common Unit will fall within this range based on negotiations between us and the underwriter at the time of pricing and will not be determined by any particular formula. We have assumed a public offering price of US$4.24 per Pre-funded Unit, the lower end of our estimated price range of US$4.24 and US$4.49 per Pre-funded Unit. The actual offering price per Pre-funded Unit will fall within this range based on negotiations between us and the underwriter at the time of pricing and will not be determined by any particular formula. Therefore, the assumed public offering prices used throughout this prospectus may not be indicative of the final offering prices.

 

We are an “emerging growth company” as that term is used in the Jumpstart Our Business Start-ups Act of 2012 and, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and future filings.

 

Neither the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

 

Investing in our securities involves a high degree of risk. See “Risk Factors” on page 19 to read about factors you should consider before buying our securities.

 

   

Per

Common

Unit

   

Per

Pre-Funded

Unit

    Total  
Public offering price   US$              US$               US$          
Underwriting discounts and commissions(1)   US$       US$       US$    
Proceeds to BriaCell Therapeutics Corp., before expenses   US$       US$       US$    

 

(1) Underwriting discounts and commissions do not include a non-accountable expense allowance equal to 1% of the initial public offering price per Common Unit and Pre-Funded Unit, as applicable, payable to the underwriters. We refer you to “Underwriting” beginning on page 123 for additional information regarding underwriters’ compensation.

 

We have granted a 45-day option to the underwriters to purchase up to additional common shares and/or Pre-funded Warrants, representing 15% of the common shares and Pre-funded Warrants sold in the offering and/or up to additional Warrants, representing 15% of the Warrants sold in the offering, solely to cover over-allotments, if any.

 

The underwriters expect to deliver the securities to investors on or about               , 2020.

 

ThinkEquity

a division of Fordham Financial Management, Inc.

 

The date of this prospectus is              , 2020

 

 
 

 

TABLE OF CONTENTS

 

  Page
Part I  
   
PROSPECTUS SUMMARY 5
   
RISK FACTORS 19
   
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS 36
   
USE OF PROCEEEDS 37
   
DILUTION 38
   
DIVIDEND POLICY 38
   
CAPITALIZATION 39
   
ENFORCEMENT OF CIVIL LIABILITIES 40
   
SELECTED CONSOLIDATED FINANCIAL DATA 41
   
MANAGEMENT’S DISCUSSION AND ANALYSIS AND RESULTS OF OPERATION 42
   
DESCRIPTION OF BUSINESS 50
   
WHERE YOU CAN GET MORE INFORMATION 88
   
LEGAL PROCEEDINGS 88
   
DIRECTORS, EXECUTIVE OFFICERS, AND SIGNIFICANT EMPLOYEES 89
   
EXECUTIVE COMPENSATION 99
   
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT 104
   
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS 105
   
DESCRIPTION OF SECURITIES 107
   
SHARES ELIGIBLE FOR FUTURE SALE 112
   
TAXATION 113
   
UNDERWRITING 123
   
MATERIAL AGREEMENTS 130
   
EXPERTS AND LEGAL MATTERS 131
   
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 131
   
EXPENSES OF THIS OFFERING 131
   
INDEX TO FINANCIAL STATEMENTS F-1
   
Part II II-1

 

3
 

 

You should rely only on the information contained in this prospectus, any amendment or supplement to this prospectus or any free writing prospectus prepared by or on our behalf. Neither we, nor the Underwriters, have authorized any other person to provide you with different or additional information. Neither we, nor the Underwriters, take responsibility for, nor can we provide assurance as to the reliability of, any other information that others may provide. The Underwriters are not making an offer to sell these securities in any jurisdiction where the offer or sale is not permitted. The information contained in this prospectus is accurate only as of the date of this prospectus or such other date stated in this prospectus, and our business, financial condition, results of operations and/or prospects may have changed since those dates.

 

The selling shareholder is offering to sell and seeking offers to buy our common shares only in jurisdictions where offers and sales are permitted.

 

Except as otherwise set forth in this prospectus, neither we nor the Underwriters have taken any action to permit a public offering of these securities outside the United States and Canada or to permit the possession or distribution of this prospectus outside the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about and observe any restrictions relating to the offering of these securities and the distribution of this prospectus outside the United States.

 

Unless the context otherwise requires, in this prospectus, the term(s) “we”, “us”, “our”, “Company”, “our company”, “BriaCell,” and “our business” refer to BriaCell Therapeutics Corp. and our subsidiaries.

 

MARKET, INDUSTRY AND OTHER DATA

 

This prospectus contains estimates, projections and other information concerning our industry, our business, and the markets for our products. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources.

 

In addition, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors.” These and other factors could cause our future performance to differ materially from our assumptions and estimates. See “Cautionary Statement Regarding Forward-Looking Statements.”

 

CURRENCY AND EXCHANGE RATES

 

All dollar amounts in this prospectus are expressed in Canadian dollars unless otherwise indicated. The Company’s accounts are maintained in Canadian dollars and the Company’s financial statements are prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board. All reference to “U.S. dollars”, “USD”, or to “US$” are to United States dollars.

 

The following table sets forth the rate of exchange for the Canadian dollar, expressed in United States dollars in effect at the end of the periods indicated, the average of exchange rates in effect during such periods, and the high and low exchange rates during such periods based on the noon rate of exchange as reported by the Bank of Canada for conversion of Canadian dollars into United States dollars.

 

On December 9, 2020, the exchange rate was US$1.00 = CAD$1.2803.

 

Canada Dollar per U.S. Dollar Noon Buying Rate    
   Average   High   Low   Period-End 
Year ended July, 31,                    
2020   1.3462    1.4496    1.2970    1.3404 
2019   1.3234    1.3642    1.2803    1.3148 
Most recent six months                    
June 2020     1.3550       1.3682       1.3383       1.3628  
July 2020     1.3499       1.3616       1.3360       1.3404  
August 2020     1.3222       1.3377       1.3042       1.3042  
September 2020     1.3228       1.3396       1.3055       1.3339  
October 2020     1.3215       1.3349       1.3122       1.3318  
November 2020     1.3068       1.3257       1.2965       1.2965  

 

4
 

 

PROSPECTUS SUMMARY

 

This summary highlights selected information contained elsewhere in this prospectus and does not contain all of the information that you should consider in making your investment decision. Before deciding to invest in our common shares, you should read this entire prospectus carefully, including the sections of this prospectus entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and the related notes included elsewhere in this prospectus. All share and per share data in this prospectus reflects a 1-for-300 reverse stock split of our common shares issued and outstanding (including adjustments for fractional shares), which will be effected prior to the date we price this offering.

 

Overview of the Company

 

BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer, with a focus on advanced breast cancer. BriaCell has completed positive proof-of-concept studies of Bria-IMT™, a whole cell targeted immunotherapy, in patients with advanced breast cancer.

 

BriaCell has been conducting a Phase I/IIa clinical trial of Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with immune checkpoint inhibitors and has initiated combination therapy with the Incyte drugs INCMGA00012 (an anti-PD-1 antibody) and epacadostat, an orally bioavailable small-molecule inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1).

 

BriaCell and Incyte Corporation have formed a non-exclusive clinical trial collaboration to evaluate the effects of combinations of novel clinical candidates. Under the agreement, Incyte and BriaCell will be evaluating novel combinations of compounds from Incyte’s development portfolio with Bria-IMT™ in advanced breast cancer patients.

 

BriaCell is also developing Bria-OTS™, an off-the-shelf personalized immunotherapy, for advanced breast cancer. Bria-OTS™ immunotherapy treatments are personalized to match the patient without the need for personalized manufacturing. Bria-OTS™ are a set of biologic drugs similar to Bria-IMT™, differing by a set of HLAs. The Bria-OTS™ cell lines will be pre-manufactured and stored frozen and ready to ship once a patient’s HLA type is known, making them “off-the-shelf.” HLA molecules are polymorphic in that they are different in some people and shared by some people with the different HLA molecules referred to as “HLA alleles” or “HLA types”. Patients will be treated with the Bria-OTS™ drugs most closely matching their HLA type, making their treatment “personalized”. Bria-OTS™, which is expected to cover over 99 percent of the patient population, is designed to produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense and complex manufacturing logistics associated with other personalized immunotherapies.

 

BriaCell’s pipeline also includes other immunotherapy cell lines in development for other cancers (including lung, prostate and melanoma), the development of other immunotherapy approaches for cancer and infectious diseases, including multi-specific binding reagents similar to Bi-specific T-cell engagers, and small molecule inhibitors of protein kinase C delta which are postulated to be effective in cancers caused by mutations in the RAS oncogene.

 

Products/Pipeline

 

Bria-IMT™

 

Bria-IMT™, BriaCell’s lead candidate, is a whole-cell immunotherapy undergoing clinical testing in patients with metastatic breast cancer who have failed at least two prior lines of therapy. BriaCell has been conducting a Phase I/IIa clinical trial of Bria-IMT™ in combination with immune checkpoint inhibitors. The combination study is being conducted at 3 clinical sites: St. Joseph Heritage Healthcare, Santa Rosa, California, United States; University of Miami/Sylvester at Plantation, Plantation, Florida, USA; Cancer Center of Kansas (CCK), Wichita, Kansas, USA; Subsequent to the establishment of a collaboration with Incyte Corporation, this study has been modified to evaluate the combination of Bria-IMT™ with INCMGA00012 (a PD-1 inhibitor) and epacadostat (an indoleamine dioxygenase (IDO) inhibitor).

 

BriaCell has achieved proof of concept based on data from a Phase I/IIa study of Bria-IMT™ in advanced breast cancer patients. In essence, BriaCell obtained evidence that patients with certain HLA molecules also present in Bria-IMT™ have a higher likelihood of responding to the Bria-IMT™ regimen with tumor shrinkage, which is consistent with results from a molecular analysis of Bria-IMT™ conducted by BriaCell. BriaCell has also obtained evidence that patients with well-differentiated (grade I) or moderately differentiated (grade II) tumors are more likely to respond. Our proof of concept data is preliminary and we will need to complete the Phase I/IIa study and additional clinical studies before the Food and Drug Administration, or FDA, assesses the efficacy, safety and tolerability of this product candidate and determines whether it will be approved for commercial sale. Specifically, BriaCell plans to continue the Phase I/IIa study of the combination of Bria-IMT™ with INCMGA00012 and epacadostat. Once sufficient data is available from this study (anticipated to include data on at least 30 patients), BriaCell will determine the design of a Phase II registration study. BriaCell will negotiate with the FDA to obtain a “Special Protocol Assessment” (SPA) of the registration study. Under the SPA, the FDA would agree with the design and endpoints of the registration study and if these endpoints are met, would agree to grant marketing approval of the drug. Completion of the Phase II registration study will permit BriaCell to submit a Biologics License Application for Bria-IMT.

 

About Bria-IMT™

 

Developed and characterized by a team of dedicated scientists and clinicians, Bria-IMT™ (SV-BR-1-GM) is a targeted immunotherapy being developed for the treatment of breast cancer. Bria-IMT™ is a genetically engineered human breast cancer cell line with features of immune cells and clinically applied as a targeted immunotherapy.

 

In short, Bria-IMT™ immunotherapy is a genetically engineered human breast cancer cell line which activates the immune system to attack and destroy breast cancer tumors.

 

Mechanism of Action of Bria-IMT™: The mechanism of action of Bria-IMT™ is currently under investigation. It is likely that the expression of certain breast cancer antigens (proteins expressed in breast cancer cells) in Bria-IMT™ generates strong T cell and potentially antibody responses resulting in recognition and destruction of cancerous cells.

 

5
 

 

Bria-IMT™ is designed to secrete granulocyte/macrophage-colony stimulating factor (GM-CSF), a factor that stimulates components of the immune system. Specifically, GM-CSF activates dendritic cells, the cells that start immune responses. These activated dendritic cells then activate T cells, a key component of the immune system, to recognize the tumor cells as foreign, and eliminate them. To amplify this action, we have combined Bria-IMT™ with other immune system activators including cyclophosphamide (used in low doses to reduce immune suppression), and interferon-α, a cytokine. We believe this approach of simultaneous activation of the immune system via different pathways will improve the immune system response to attack and destroy cancer cells.

 

Using BriaCell’s novel technology platform and our strong R&D capabilities, we plan to develop Bria-OTS™, a personalized off-the-shelf immunotherapy for breast cancer, and similar immunotherapy cell lines for other cancer indications.

 

Bria-OTS™ is under development as an off-the-shelf personalized immunotherapy for advanced breast cancer.
   
The concept for Bria-OTS™ comes from BriaCell’s work with Bria-IMT™, where we noted that if a patient “matches” Bria-IMT™ in their HLA type, they were more likely to respond.
   
HLA molecules are the molecules that start immune responses but are polymorphic – i.e. they are different in different people, although some people will share the same HLA molecules (referred to as “HLA alleles” or “HLA types”).

 

Bria-OTS™ is made from cell lines that are genetically engineered to expresses the immune boosters GM-CSF and interferon-α, as well as specific HLA types (a.k.a. alleles).
   
Different cell lines are being pre-manufactured to express 15 different HLA types matching >99% of the overall breast cancer patient population (the methodology in determining that Bria-OTS would match 99% of the breast cancer population is discussed on pages 58 and 59 herein).
   
Using the BriaDx™, a companion diagnostic test performed via buccal swabs inside the patient’s mouth, the suitable personalized treatment will be selected for each patient for administration.
   
This approach allows personalized treatment without the need for personalized manufacturing. Additionally, it saves time and skips expensive and complicated manufacturing procedures associated with other personalized treatments.
   
Bria-OTS™ cell lines are being engineered with the goal of transferring them to production in 2020 and commencing clinical evaluation in 2021 (expected authorization by FDA and expected first patient to be dosed in 2021) with safety and efficacy data expected to be released during 2021 and 2022.

 

BriaDx™

 

BriaDx™ is a diagnostic test that BriaCell is developing to identify the patients most likely to respond to Bria-IMT™. Currently, BriaDx™ includes HLA typing of the patients as patients having HLA alleles also present in Bria-IMT™ appear to have a higher likelihood of responding to the Bria-IMT™ regimen with tumor regression (“shrinkage”). Additional markers of potential diagnostic use are being explored based on the expression of specific biomarkers in the responder (i.e. biomarkers which identify the patients for which Bria-IMT™ immunotherapy appears more effective) vs the non-responder patients from clinical studies of Bria-IMT™ in advanced breast cancer patients.

 

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Blood including circulating tumor cells from the patients is analyzed using cutting-edge technologies including gene expression analysis and assessment of the levels of antibodies predicted to bind to Bria-IMTTM.

 

The insights gained from biomarker studies conducted to date have provided us with a solid basis for the development of Bria-OTS™, an off-the-shelf personalized immunotherapy which would match over 99% of patients with advanced breast cancer.

 

BriaDx™ is being developed to help understand which patients are most likely to respond to Bria-IMT™ targeted immunotherapy. Based on the proposed mechanism of action of Bria-IMT™ (see Figure below) HLA molecules play a key role inducing cellular immune responses to Bria-IMT™ which boosts the patient’s immune response to their cancer.

 

HLA molecules are polymorphic, in that they are different in different individuals but shared by some individuals (similar to eye color). Based on our clinical data to date we hypothesize that patients with HLA alleles also present in Bria-IMT™ have a higher likelihood of responding to the Bria-IMT™ regimen with tumor regression (“shrinkage”). Therefore, BriaDx™, a companion diagnostic test, determines the patients’ HLA types.

 

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Available Clinical Data for Treatment with the Bria-IMT™ Regimen

 

BriaCell conducted three Proof of Concept clinical trials, one using parental SV-BR-1 cells and the other two using Bria-IMT™ (i.e., genetically engineered SV-BR-1 cells – producing GM-CSF also called SV-BR-1-GM), in metastatic (i.e., Stage IV) breast cancer patients who had failed prior treatments. The patients were treated with the Bria-IMT™ regimen according to the following schedule, and the results are summarized starting on page 55 herein.

 

Mechanism of Action of BRIA-IMT™ and BRIA-OTS™

 

The mechanism of action of Bria-IMT™/Bria-OTS™ is currently under investigation.

 

We believe that Bria-IMT™/Bria-OTS™ activates the patient’s immune system to recognize tumor cells and destroy them. We hypothesize that Bria-IMT™/Bria-OTS™ exerts its action via the patient’s antigen-presentation system {i.e. the system that presents antigen material on the surface of cells for recognition by the T cells of the immune system as either self (i.e., safe) or foreign (i.e., to be destroyed)}. Specifically, Bria-IMT™/Bria-OTS™ is thought to stimulate dendritic cells, a key component of the antigen-presenting system, to display certain immunogenic (i.e., immune response-generating) protein fragments to T cells, which activates the T cells to destroy the tumor cells either directly, or indirectly by inducing a humoral (antibody-generating) immune response. In addition, we also have shown that Bria-IMT™ is capable of directly stimulating T cells thereby potentially adding additional therapeutic benefits. The latter property of Bria-IMT™ is the basis of the Bria-OTS™ project as it requires HLA matching between the therapeutic cells and the patient.

 

Our preliminary analyses have shown several up-regulated genes in Bria-IMT™ that encode proteins known to be immunogenic (i.e. immune response-generating), suggesting that Bria-IMT™ can stimulate the immune system against the cancer cells.

 

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Bria-IMT™ is a human breast cancer cell line which expresses Her2/neu (a protein well known for its overexpression in breast cancer but also associated other epithelial malignancies including ovarian, pancreatic, colon, bladder and prostate cancers). Bria-IMT™ has been engineered to produce and secrete granulocyte/macrophage-colony stimulating factor (GM-CSF), a protein that promotes dendritic cell function, a key component of the immune system, and hence activates the immune system.

 

BRIA-IMT™ & BRIA-OTS™

 

Potential Mechanisms of Specific Immune Activation in Advanced Breast Cancer

 

 

 

1. Bria-IMT/OTS™ produces breast cancer antigens (proteins made by breast cancer cells)
   
2. Bria-IMT/OTS™ secretes GM-CSF which further promotes dendritic cell-based antigen presentation (boosts the response)
   
3. Breast cancer antigens are taken up by dendritic cells and “presented” to CD4+ and CD8+ T cells implicated in tumor destruction.
   
4. Bria-IMT/OTS™ directly stimulates cancer fighting CD4+ and CD8+ T cells (further boosts the response)
   
5. Bria-IMT/OTS™ biological activity depends on HLA matching of Bria-IMT/OTS™ and the patient
   
6. Based on these observations, BriaCell is extending this technology to other types of cancer by developing additional immunotherapy cell lines. These include Prostate Cancer (novel immunotherapy cell line 1 or NICL1), non-small cell lung cancer (NICL2) and melanoma (NICL3). Production of these NICLs is anticipated to commence in 2021 and IND filings for these NICLs are anticipated starting in 2022. Each of these IND filings is expected to require an additional ~US$1,000,000.

 

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Clinical Trials

 

Phase I/IIA Combination Study of BRIA-IMT™ with Immune Checkpoint Inhibitors in Advanced Breast Cancer

 

The FDA approved the combination study of Bria-IMT™ with immune checkpoint inhibitors in advanced breast cancer (third line or later). The initial study used pembrolizumab (Keytruda, purchased by the Company as the Company does not have an agreement with Merck for the supply of Keytruda). The Company dosed 11 patients with this combination and no dose limiting toxicities were observed. Additionally, evidence of additive or synergistic activity was observed.

 

The combination with Keytruda was discontinued and the study was subsequently modified to use a combination of Bria-IMT with the Incyte PD-1 inhibitor (INCMGA00012) and epacadostat. In October 2020, the Company announced that median OS of 13.3 months has been observed in this study and that median OS had reached 14 months in patients with Grade I/II tumors. The Company anticipates additional safety and efficacy data for the combination of Bria-IMT™ with INCMGA00012 and epacadostat to be released between the fourth quarter of 2020 and throughout 2021 and 2022.

 

Rationale for the Combination Study of BRIA-IMT™ with Immune Checkpoint Inhibitors

 

The immune checkpoint inhibitors such as anti-PD-1 antibodies have come to the forefront in the fight against cancer with substantial benefits for some patients. Most recently, the significance of immune checkpoint inhibitors was recognized by the Nobel committee by awarding Dr. Tasuku Honjo and Dr. James P. Allison with the 2018 Nobel Prize in Physiology or Medicine (Scientists behind game-changing cancer immunotherapies win Nobel medicine prize), validating the Company’s decision to initiate a combination therapy with the immune checkpoint inhibitors.

 

Drs. Alison and Honjo independently, using different strategies, showed a new approach of treating patients by awakening certain cells of the immune system (T cells) to attack tumors. This new approach of treating patients with immune checkpoint inhibitors (such as anti-PD-1 antibodies), designed to overcome immune suppression in cancer patients, is revolutionizing the fight against cancer.

 

In 2010 an important pre-clinical study by Dr. Allison’s group showed that combination with anti-PD-1 antibodies potentiated the tumor-destroying effect of melanoma cells engineered to produce granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system, compared to the treatment with the GM-CSF producing cells alone. Bria-IMT™ similarly uses a breast cancer cell line which produces GM-CSF. Bria-IMT™ has also been shown to indirectly and directly stimulate T cells, and hence boost the immune system. BriaCell has published these findings in a leading immunology journal. It is important to note that PD-1 inhibitors have not been shown to work on their own in breast cancer.

 

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BriaCell & Incyte Collaboration and Supply Agreement

 

Non-exclusive clinical trial collaboration to evaluate the effects of combinations of novel clinical candidates

 

The clinical study will focus on (but not limited to) BriaCell’s lead candidate, Bria-IMT™, in combination with Incyte’s selected compounds for advanced breast cancer.
   
Incyte to provide compounds from its development portfolio, including INCMGA0012, an anti-PD-1 monoclonal antibody, and epacadostat, an IDO1 inhibitor, for use in combination studies with BriaCell’s lead candidate, Bria-IMT™.
   
Incyte is a global biopharmaceutical company focused on discovering and developing novel therapeutics in oncology and other serious diseases.
   
Incyte has a deep and rich pipeline in immuno-oncology with numerous molecular targets including PD-1, IDO, GITR, OX40, TIM-3, LAG-3, ARG, AXL/MER and PD-L1xCD137
   
The first 6 patients will receive the Bria-IMT™ regimen in combination with INCMGA00012. Once safety of the combination has been established, subsequent cohorts will receive a triple combination of the Bria-IMT™ regimen with INCMGA00012 and epacadostat.
   
The design of the clinical study is shown below. Dosing of the novel combinations commenced in the fourth quarter of 2019.
   
The Company anticipates additional safety and efficacy data to be released between the fourth quarter of 2020 and throughout 2021 and 2022.
   
Pending discussions with the Food and Drug Administration (FDA), a registration study focused on, but not limited to, Bria-IMT™, in combination with Incyte’s selected compounds for advanced breast cancer is planned to commence in late 2021 with the Bria-OTS™ program following by approximately 6 quarters.

 

Additional data was presented at the American Association for Cancer Research (AACR) San Antonio Breast Cancer Meeting on December 9-11, 2020. The data presented summarized the clinical and pathological data of the Bria-IMT™ monotherapy (i.e. the Bria-IMT™ regimen alone) study and Phase I/IIa clinical study of Bria-IMT™ in combination with immune checkpoint inhibitors including pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.), and more recently, Incyte’s INCMGA00012 (by Incyte Corporation), in advanced breast cancer. 30 patients were treated with the Bria-IMT™ regimen (19 with the Bria-IMT™ regimen alone, 4 who began on the Bria-IMT™ regimen and transitioned to combination with a combination with Incyte’s INCMGA00012, and 7 with combination therapy with of Bria-IMT™ with KEYTRUDA®). 11 of those patients had moderately-well differentiated tumors. 70% of these patients who were able to develop an immune response showed disease control suggesting that the Bria-IMT™, with a molecular signature most closely related to moderately-well differentiated tumors, may result in disease control especially in patients with moderately-well differentiated tumors. These patients were very heavily pre-treated with a median of 7 prior systemic therapy regimens (including chemotherapy, biological and “targeted” therapy). The median Progression-free survival (PFS) of this cohort was 5.7 months in the monotherapy study, and 6.9 months in combination therapy. Of the group, there were 9 patients with evaluable lesions including 6 with stable disease and 2 with partial responses according to RECIST criteria. One patient with stable disease had a marked reduction in numerous non-target lesions. The data suggests clinical and survival benefit for patients with moderately-well differentiated tumors who were treated with the Bria-IMT™ regimen with or without check point inhibitors. Notably, the survival benefit was higher in the group that received the Bria-IMT™ regimen with check point inhibitors suggesting an additive or synergistic effect.

 

The median overall survival (OS) for the combined monotherapy and combination therapy was 12.5 months (data on 6 patients with moderately-well differentiated tumors). An OS of 7.2-9.8 months in similar patients with metastatic breast cancer in the third line setting has recently been published (Kazmi S, et al. “Overall survival analysis in patients with metastatic breast cancer and liver or lung metastases treated with eribulin, gemcitabine, or capecitabine.” Breast Cancer Res Treat. 2020). This suggests a potentially significant survival benefit for the patients treated with the Bria-IMT™ regimen alone or in combination with check point inhibitors.

 

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Market

 

It is estimated that in 2019, approximately 268,600 women will be diagnosed with breast cancer in the United States. According to the National Breast Cancer Foundation, on every two minutes an American woman is diagnosed with breast cancer and more than 40,500 die each year. Although about 100 times less common than in women, breast cancer also affects men. It is estimated that the lifetime risk of men getting breast cancer is about 1 in 1,000, and the ACS estimates that approximately 2,670 new cases of invasive male breast cancer will be diagnosed and approximately 500 men will die from breast cancer in 2019.

 

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According to the May 2019 “Global Oncology Trends 2019” report by the IQVIA Institute, the global market for cancer drugs (including immunotherapy drugs) is expected to reach nearly US$240 billion by the end of 2023, growing at a compound annual growth rate, or CAGR of 9-12% between 2019 and 2023.

 

Marketing and Sales Strategy

 

The product will initially be marketed to oncologists who are well versed in the use of immunotherapy for cancer. Partnering with other pharma companies in order to market combinations with a number of drugs is also an option that we intend to pursue. This study will utilize a frozen formulation which consists of irradiated SV-BR-1-GM cells in viable freezing media. This formulation will permit stockpiling of the immunotherapy so that it can be sent on demand to clinical sites. The eventual goal is to reach all oncologists who treat late stage breast cancer either by direct outreach or by partnering with another company that has an established presence in the oncology space.

 

Other Commercial Considerations

 

There is a high unmet medical need in late stage breast cancer, providing potential for accelerated approval of Bria-IMT™. The FDA is interested in facilitating the availability of novel therapies of patients with unmet medical needs, especially those that can target the population most likely to respond. In addition, Bria-IMT™ may fit the description of an orphan drug, especially if HLA matching and/or limitation to grade I/II tumors is required. These two facts may help facilitate accelerated approval of Bria-IMT™.

 

Production and Marketing Plan

 

Bria-IMT™ cells grow in simple tissue culture media and are irradiated prior to inoculation. Bria-IMT™ manufacturing will be performed by Contract Manufacturing Organizations (CMOs). Recently we have been working with KBI Biopharma, Inc. who have developed a frozen formulation, where the cells are grown, harvested and irradiated followed by cryopreservation in a viable state. The cells are stockpiled and shipped directly to clinical sites for inoculation. Each lot of Bria-IMT™ is tested for potency (GM-CSF production), identity (HER2+ and ER/PR-) and adventitious agents to assure that each patient receives a safe and effective treatment. To date, there have been no issues with these tests. Additional manufacturing facilities have been evaluated and may be enlisted as demand grows.

 

Earlier Phase Programs

 

BriaCell has recently filed provisional patent applications describing:

 

  Coronavirus Immunotherapy
  Antibody-Based Treatment of Infectious Diseases
  Novel Therapeutics for Cancer
  Novel Immune Therapies for Multiple Disease Indications
  Novel Treatment and Diagnosis of Coronavirus Disease

 

The Coronavirus Immunotherapy patent application, filed on April 10, 2020, entitled, “INDUCING IMMUNE RESPONSES BY TRANSFORMING CANCER CELLS INTO ANTIGEN-PRESENTING CELLS”, is based on molecular analyses of the Company’s lead anti-tumor product candidate. Antigen-presenting cells are the cells that typically start immune responses. BriaCell’s whole-cell immunotherapies are designed to stimulate the immune system to recognize and destroy the patient’s tumors by acting as antigen-presenting cells that stimulate the patient’s cancer-cell-recognizing immune cells. The new patent application by BriaCell scientists expands on this paradigm by proposing additional cellular therapeutics designed to activate immune cells recognizing SARS-CoV-2 (the coronavirus causing COVID-19) antigens. The patent application seeks protection for, among others, new whole-cell therapeutics and methods for their use. These are designated “Novel Immunotherapy Cell Lines (NICL1 – Prostate Cancer, NICL2 – non-small cell lung cancer, NICL3 – melanoma, NICL-CoV-2)”. IND filings for NICL1 is anticipated to be made in 2022. Each IND filing requires an additional ~US$1,000,000.

 

The Antibody-Based Treatment of Infectious Diseases patent application, filed on April 20, 2020, entitled, “COMPUTER-GUIDED DESIGN OF ANTIBODIES INCLUDING NEUTRALIZING SARS-CoV-2 BINDING AGENTS”, outlines compositions and methods for generating antibodies to neutralize SARS-CoV-2 (the coronavirus causing COVID-19) using computer-based simulation technology. Such antibodies are envisioned to prevent and treat the life-threatening symptoms of COVID-19. The use of computer simulation creates highly targeted antibodies by improving pre-existing antibodies. The improvements include, but are not limited to, creating higher affinity and/or specificity antibodies to the SARS-CoV-2 Spike protein (the protein which the virus uses to infect cells) versus the unmodified antibody. The resulting therapeutic antibodies are expected to quickly and specifically recognize the SARS-CoV-2 virus, bind to it, and neutralize it. The patent application also provides compositions and methods, using similar technologies, for cancer-directed antibodies. The patent application seeks protection for the design of new therapeutic antibodies and methods for their use. These are designated “Antibodies for SARS-CoV-2”. If a suitable sponsor or partner is found for this program, an IND filing for this treatment is anticipated to be made in 2022 and requires an additional ~US$1,000,000.

 

The patent application for Novel Immune Therapies for Multiple Disease Indications, filed on May 15, 2020, entitled, “MULTI-VALENT IMMUNOSTIMULATORS FOR INFECTIOUS DISEASES, AUTOIMMUNE DISEASES, ALLERGIC DISEASES AND CANCER”, describes a platform to generate multi-valent reagents carrying an antigen (such as an antigen from SARS-CoV-2) and delivering it to immune cells such as dendritic cells, a type of antigen-presenting cell crucial for the induction and modulation of immune responses. The expected effect is a targeted therapy envisioned to selectively destroy infectious agents or cancer cells with minimal negative effect on normal cells. This may mean less severe side effects for the treated patients compared to other therapies. The technology also has uses for autoimmune diseases and allergic diseases. The Company cautions that these novel therapeutics are still under early-stage research and development and is not making any express or implied claims as to their success in cancer treatment or commercial viability. The patent application seeks protection for, among others, the design of new therapeutics and methods for their use. These are designated “Novel ImmunoStimulators (NIS-CoV-2)”. If a suitable sponsor or partner is found for this program, an IND filing for this treatment is anticipated to be made in 2022 and requires an additional ~US$1,000,000.

 

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The Company cautions that COVID-19 therapeutic development is still under early-stage research and development and is not making any express or implied claims that it has the ability to treat, prevent or eliminate the COVID-19 virus at this time.

 

The patent application for Novel Therapeutics for Cancer, filed on April 23, 2020, is entitled, “METHODS FOR INDUCING AND ENHANCING ANTI-CANCER IMMUNE RESPONSES USING NOVEL MOLECULAR CONSTRUCTS”. It outlines the development and use of multi-specific binding reagents that simultaneously bind to an immune cell and a cancer cell, or just to a cancer cell, and activate the immune system against the cancer cells. The novel binding reagents are designed to act, among others, as potent immune cell activators/immune checkpoint inhibitors without the toxicity of current checkpoint inhibitors. The expected effect is a highly targeted therapy envisioned to selectively destroy cancer cells without affecting normal (non-cancerous) cells. This may mean less severe side effects for the treated cancer patients compared to alternative therapies. The Company cautions that these novel therapeutics are still under early-stage research and development and is not making any express or implied claims as to their success in cancer treatment or commercial viability. The patent application seeks protection for, among others, the design of new therapeutics and methods for their use. These are designated “Bria-TILs-Rx”. IND filings for Bria-TILs-Rx for the treatment of prostate cancer and epithelial and glandular cancer, respectively, are anticipated to be made in 2022 and require an additional ~US$1,000,000 each.

 

The patent application for Novel Treatment and Diagnosis of Coronavirus Disease, filed on June 22, 2020, entitled “MULTI-VALENT DECOY RECEPTORS FOR DIAGNOSIS AND/OR TREATMENT OF CORONAVIRUS INFECTION”, describes a platform to generate multi-valent molecular constructs (decoy receptors) that have the potential to prevent coronaviruses including the SARS-CoV-2 virus (the virus that causes Coronavirus Disease 2019 (COVID-19)) from entering (infecting) healthy host cells. Multi-valent constructs described in the patent application are believed to have both therapeutic and diagnostic potential, the latter in the context of determining whether a patient has developed coronavirus-specific antibodies. The Company cautions that these novel therapeutics are still under early-stage research and development and is not making any express or implied claims as to their success in treatment or commercial viability. The patent application seeks protection for, among others, the design of new therapeutics and diagnostics and methods for their use.

 

On October 28, 2020, BriaCell entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Health and Human Services, as represented by National Cancer Institute (NCI). Under the CRADA, the National Cancer Institute and BriaCell Therapeutics Corp. will work together to conduct preclinical studies to develop and test BriaCell Therapeutic Corp.’s proprietary Bria-OTS cellular immunotherapy as a treatment for cancer to improve and broaden applicability of this therapeutic strategy. Under the terms of the CRADA, BriaCell will provide funding (totaling $433,400 over three years) to support the project. The NCI estimates that 1.3 person-years of effort per year will be required to complete the CRADA research which includes the development of a mouse model of this therapeutic strategy. BriaCell and NCI will be using their combined expertise in tumor immunology, molecular biology and development of cellular therapies to design studies which are intended to trigger the immunologic pathways necessary to create potent immune responses against cancer. The goal of the collaboration is to develop novel therapeutics for future clinical collaborations, allowing cancer patients to potentially benefit from potent and personalized cancer immunotherapy.

 

Risks Related to our Business and this Offering

 

Our business and this offering are subject to numerous risks, as more fully described in the section entitled “Risk Factors” immediately following this prospectus summary. You should read these risks before you invest in our securities. In particular, our risks include, but are not limited to, the following:

 

  We have a history of losses, may incur future losses and may not achieve profitability;
  We are an early stage development company;
  We have an unproven market for our product candidates;
  We are heavily reliant on third-parties to carry out a large portion of our business;
  Pre-clinical studies and initial clinical trials are not necessarily predictive of future results;
  We must obtain additional capital to continue our operations;
  We are highly dependent on our key personnel;
  The report of our independent registered public accounting firm expresses substantial doubt about our ability to continue as a going concern;
  We may not succeed in completing the development of our products, commercializing our products or generating significant revenues;
  We may not successfully develop, maintain and protect our proprietary products and technologies;
  Changes in legislation and regulations may affect our revenue and profitability;
  If we or our licensees are unable to obtain U.S., Canadian and/or foreign regulatory approval for our product candidates, we will be unable to commercialize our therapeutic candidates;
  Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results;
  An active trading market for our common shares may not develop on Nasdaq and our securityholders may not be able to resell their common shares or Warrants;
  The Warrants may not have any value;
  Without an active trading market, the liquidity of the Pre-funded Warrants and Warrants will be very limited and the Warrants and Pre-Funded Warrants may not have any value;
 

The Pre-Funded Warrants are not listed or quoted on any trading market or exchange;

  Future issuance of our common shares could dilute the interests of existing shareholders;
  We have a significant number of options and warrants outstanding, and while these options and warrants are outstanding, it may be more difficult to raise additional equity capital;
  We are a foreign private issuer and, as a result, we are not subject to U.S. proxy rules and are subject to reporting obligations that, to some extent, are more lenient and less frequent than those applicable to a U.S. issuer;
  If you purchase our common shares in this offering, you will incur immediate and substantial dilution in the book value of your shares; and
  Our management will have broad discretion in the use of the net proceeds from this offering and may allocate the net proceeds from this offering in ways that you and other shareholders may not approve.

 

Corporate Background

 

We were incorporated in the province of British Columbia on July 26, 2006. Our common shares have been quoted on the OTCQB under the symbol BCTXF, on the TSX Venture Exchange under the symbol “BCT.V” and on the Frankfurt Stock Exchange under the symbol “8BTA”.

 

Our principal executive office is located at Suite 300 – 235 15th Street, West Vancouver, British Columbia, V7T 2X1 and our telephone number in Canada is (604) 921-1810. Our web address is https://briacell.com/. The information contained on our website or available through our website is not incorporated by reference into and should not be considered a part of this prospectus, and the reference to our website in this prospectus is an inactive textual reference only. Any website references (URL’s) in this prospectus are inactive textual references only and are not active hyperlinks. The contents of our website is not part of this prospectus, and you should not consider the contents of our website in making an investment decision with respect to our common shares. Paracorp Incorporated is our agent in the United States, and its address is 2804 Gateway Oaks Drive #100, Sacramento, CA 95833, Tel: (888) 280-6563, Fax: (800) 603-5868; Attn: Katelyn Bean (kbean@myparacorp.com).

 

The Company’s corporate offices in the United States are located at 820 Heinz Avenue, Berkley, California 94710. The Company’s two wholly owned subsidiaries BriaCell Therapeutics Corp., a Delaware corporation, and Sapientia Pharmaceuticals Inc., a Delaware corporation, were formed on April 3, 2014 and September 20, 2012 respectively.

 

In February and March 2019, the Company’s board of directors (the “Board”) was substantially restructured with the appointment of Jamieson Bondarenko, Dr. Rebecca Taub and Vaughn C. Embro-Pantalony to replace three resigning directors. Additionally, on August 12, 2019, Richard Berman was appointed to our Board but later resigned in October 26, 2020 citing other commitments. On November 24, 2020, Martin Schmieg rejoined the Board. After these restructuring events, the current Board consists of:

 

  Dr. William V. Williams, Director and Chief Executive Officer;
     
  Jamieson Bondarenko, Director and Chairman of the Board;
     
  Dr. Charles Wiseman, Director;
     
  Dr. Rebecca Taub, Director
     
  Vaughn C. Embro-Pantalony, Director; and
     
  Martin Schmieg, Director

 

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Implications of Being an “Emerging Growth Company” and a Foreign Private Issuer

 

As a company with less than US$1.07 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. These provisions include:

 

  reduced executive compensation disclosure;
     
  exemptions from the requirement to hold a non-binding advisory vote on executive compensation, including golden parachute compensation; and
     
  an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002.

 

We may take advantage of these provisions until we are no longer an emerging growth company. We would cease to be an emerging growth company upon the earlier to occur of: (1) the last day of our fiscal year following the fifth anniversary of the completion of this offering; (2) the last day of the fiscal year in which we have total annual gross revenue of US$1.07 billion or more; (3) the date on which we have issued more than US$1.0 billion in nonconvertible debt during the previous three years; or (4) the date on which we are deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission, or the SEC.

 

We intend to report under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as a non-U.S. company with foreign private issuer status. Even after we no longer qualify as an emerging growth company, as long as we continue to qualify as a foreign private issuer under the Exchange Act, we will be exempt from certain provisions of the Exchange Act that are applicable to U.S. domestic public companies, including:

 

  the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations with respect to a security registered under the Exchange Act;
     
  the sections of the Exchange Act requiring insiders to file public reports of their share ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and
     
  the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial statements and other specified information, and current reports on Form 8-K upon the occurrence of specified significant events, although we report our results of operations on a quarterly basis under the Canadian securities laws.

 

Both foreign private issuers and emerging growth companies are also exempt from certain more stringent executive compensation disclosure rules. Thus, even if we no longer qualify as an emerging growth company, but remain a foreign private issuer, we will continue to be exempt from the more stringent compensation disclosures required of companies that are neither an emerging growth company nor a foreign private issuer.

 

We would cease to be a foreign private issuer at such time as more than 50% of our outstanding voting securities are held by U.S. residents, and any one of the following three circumstances applies: (i) the majority of our executive officers or directors are U.S. citizens or residents, (ii) more than 50% of our assets are located in the United States or (iii) our business is administered principally in the United States.

 

In this prospectus, we have taken advantage of certain of the reduced reporting requirements as a result of being an emerging growth company and a foreign private issuer. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold equity securities.

 

Reverse Split

 

On October 22, 2019, our shareholders approved a reverse stock split of our issued and outstanding common shares at a ratio of between 1-for-2 and 1-for-300, with the specific ratio and effective time of the reverse stock split to be determined by our Board. In November, our Board approved a 1-for-300 reverse stock split, or the Reverse Split, which was implemented on January 2, 2020. The Reverse Split was intended to allow us to meet the minimum share price requirement of The Nasdaq Capital Market. We have applied for listing of our common shares and Warrants on The Nasdaq Capital Market, which listing we expect to occur upon the consummation of this offering. However, there are no assurances that such listing application will be approved. Nasdaq has indicated that it will not approve our listing if the per Common Unit offering price in this offering is less than US$4.25. If the application is not approved, our common shares will continue to be traded on the OTCQB, TSXV and Frankfurt Stock Exchange and we will be unable to complete this offering.

 

15
 

 

THE OFFERING

 

The information below is only a summary of more detailed information included elsewhere in this prospectus. This summary may not contain all the information that is important to you or that you should consider before making a decision to invest in our securities. Please read this entire prospectus, including the risk factors, carefully.

 

Common Units offered   3,268,765 Common Units, each consisting of one common share and one Warrant, each whole Warrant exercisable for one common share. The Warrants included within the units are exercisable immediately, have an exercise price of US$___ per share, equal to 125% of the public offering price of one unit, and expire five years from the date of issuance. The common shares and Warrants that are part of the Common Units are immediately separable and will be issued separately in this offering.
     
Pre-Funded Units offered  

We are also offering to those purchasers, if any, whose purchase of Common Units in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common shares immediately following the consummation of this offering, the opportunity to purchase, if the purchaser so chooses, pre-funded units (each a “Pre-funded Unit”) in lieu of Common Units that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common shares. Each Pre-funded Unit will consist of a pre-funded warrant to purchase one common share at an exercise price of US$0.01 per share (each a “Pre-funded Warrant”) and a Warrant. The purchase price of each Pre-funded Unit is equal to the price per Common Unit being sold to the public in this offering, minus US$0.01. The Pre-funded Warrants will be immediately exercisable and may be exercised at any time until all of the Pre-funded Warrants are exercised in full. For each Pre-funded Unit we sell, the number of Common Units we are offering will be decreased on a one-for-one basis. We are offering a maximum of 3,268,765 Pre-funded Units. Because we will issue one Warrant as part of each Common Unit or Pre-funded Unit, the number of Warrants sold in this offering will not change as a result of a change in the mix of the Common Units and Pre-funded Units sold. This prospectus also relates to the offering of the common shares issuable upon exercise of the Pre-funded Warrants.

     

Public offering price

 

The assumed public offering price is US$4.25 per Common Unit (being the low end in the estimated offering price range for the Common Units of between US$4.25 and US$4.50) and US$4.24 per Pre-Funded Unit (being the low end in the estimated offering price range for the Pre-Funded Units of between US$4.24 and US$4.49).

     
Over-allotment option  

We have granted the underwriters a 45-day option to purchase up to additional common shares and/or Pre-Funded Warrants, representing 15% of the common shares and Pre-Funded Warrants sold in the offering and/or up to additional Warrants, representing 15% of the Warrants sold in the offering.

 

The purchase price to be paid per additional Common Unit or Pre-Funded Warrant by the underwriters shall be equal to the public offering price of one Common Unit or one Pre-funded Warrant, as applicable, less the underwriting discount, and the purchase price to be paid per additional Warrant by the underwriters shall be US$0.00001.

     
Common shares outstanding prior to this offering   771,962 common shares, after giving effect to the Reverse Split.
     
Common shares outstanding after this offering (1)(2)  

4,040,727 shares (or 4,531,042 shares if the underwriters exercise their over-allotment option in full).

     
Use of proceeds   We expect to receive approximately US$12,000,000 in net proceeds from the sale of securities offered by us in this offering (approximately US$14,000,000 if the underwriters exercise their over-allotment option in full), after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us, based on an assumed offering price of US$4.25 per Common Unit. We intend to use the net proceeds from this offering to advance our clinical trials and as further set forth in the “Use of Proceeds” section.
     
Risk factors   An investment in our securities involves significant risks. See the section entitled “Risk Factors” and other information included in this prospectus for a discussion of factors you should carefully consider before deciding to invest in our securities.
     
Lock-up   We and our directors and executive officers have agreed with the underwriters not to offer, issue, sell, contract to sell, encumber, grant any option for the sale of or otherwise dispose of any of our securities for a period of six months commencing on the date of this prospectus. See “Underwriting” beginning on page 123.
     
Market and trading symbol for our common shares and Warrants   Our common shares are currently quoted on the OTCQB under the symbol “BCTXF”, on the TSXV under the symbol “BCT.V” and on the Frankfurt Stock Exchange under the symbol “8BTA”. We have applied to list the common shares and Warrants included within the Common Units and Pre-funded Units on the Nasdaq Capital Market under the symbols “BCTX” and “BCTXW”, respectively. No assurance can be given that such listings will be approved. We do not plan to list the Pre-funded Warrants on any market or exchange.

 

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(1) The number of common shares to be outstanding after this offering is based on 771,962 common shares outstanding as of December 10, 2020 and excludes the following:

 

  252,606 common shares issuable upon the exercise of outstanding warrants, at a weighted average exercise price of $32.82;
     
  13,790 common shares issuable upon the exercise of outstanding compensation warrants, at a weighted average exercise price of $45.00;
     
  912 common shares issuable upon the granting of 912 warrants arising from the exercise of 912 compensation warrants at a weighted average exercise price of $90.00; and
     
  18,052 common shares issuable upon the exercise of outstanding options, at a weighted average exercise price of $46.

 

(2) Except as otherwise indicated herein, all information in this prospectus assumes no sale of Pre-funded Units in this offering, no exercise of the warrants being offered in this offering, no exercise of the underwriters’ over-allotment option and no exercise of the underwriter warrants.

 

17
 

 

Summary Financial Data

 

The summary financial information set forth below has been derived from our audited financial statements for the fiscal years ended July 31, 2020, 2019, 2018, 2017, 2016 and 2015. You should read the following summary financial data for the years ended July 31, 2020 and 2019 together with our historical financial statements and the notes thereto included elsewhere in this prospectus and with the information set forth in the section titled “Management’s Discussion and Analysis of Financial Conditions and Results of Operations”. The audited financial statements for the years ended July 31, 2018, 2017, 2016 and 2015 are not included in this prospectus.

 

       As of July 31, 
   2020   2019   2018   2017   2016 
                     
Balance Sheet Data                           
Cash and cash equivalents    26,104     192,916    938,448    1,264,429    171,865 
Total Assets    641,684     546,259    2,977,140    2,039,199    1,091,587 
Total Liabilities    5,061,306     1,392,396    1,745,850    1,104,147    63,470 
Total Shareholders’ Equity (deficit)    (4,419,622 )   (846,137)   1,231,290    935,052    1,028,117 

 

         Year ended July 31, 
   2020     2019   2018   2017   2016   2015 
Operating Data                                 
Revenues and other income    -      -    -    -    -      
                                  
Expenses:                                 
Research costs    2,980,144      4,917,287    3,112,579    2,125,941    944,942      
General and administrative costs    1,857,465      1,244,471    1,387,713    820,281    584,105      
Share-based compensation    2,071      60,586    476,211    272,014    648,149      
Listing costs           -    -    -    -      
Surrender of royalty rights    -      -    -    -    -      
Total expenses    4,839,680      6,222,344    4,976,503    3,218,236    2.177,196      
                                  
Operating loss    (4,944,221 )    (6,222,344)   (4,976,503)   (3,218,236)   (2.177,196)     
Interest income    -      12,004    15,991    6,428    4,738      
Interest expenses    (36,216 )    (31,317)   (20,364)   -    -      
Change in fair value of convertible debt    (79,119 )    420,585    (407,709)   -    -      
Gain from government grant     28,604      -    -    -    -      
Loss on available for sale investments    -      -    -    -    (27,763)     
Foreign exchange gain (loss)    (17,810 )    31,410    (24,078)   (8,913)   (14,561)     
     (104,541 )    432,682    (436,160)   (2,485)   (37,586)     
                                  
Loss For The Period    (4,944,221 )    (5,789,662)   (5,412,663)   (3,220,721)   (2,214,782)     
                                  
Items That Will Subsequently Be Reclassified To Profit Or Loss                                 
Foreign currency translation adjustment    (46,079 )    (18,781)   (33,340)   41,828    18,575      
Unrealized loss on available for sale investments    -      -    -    -    (6,892)     
                                  
Items Reclassified To Profit Or Loss    -                            
Reclass of unrealized losses on available for sale investments    -      -    -    -    27,763      
                                  
Comprehensive loss for the year    (4,990,300 )    (5,808,443)   (5,446,003)   (3,178,893)   (2,175,336)     
                                  
Basic and Fully Diluted Loss Per Share    (6.99 )    (10.02)   (12.73)   (9.36)   (7.54)     
Weighted Average Number Of Shares Outstanding    713,889      579,664    427,815    339,707    288,472      

 

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RISK FACTORS

 

An investment in our common shares involves a high degree of risk. You should carefully consider the following factors and other information in this prospectus before deciding to invest in us. If any of the following risks actually occur, our business, financial condition, results of operations and prospects for growth would likely suffer. As a result, you could lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may materially and adversely affect our business, financial condition and results of operations. See also “Cautionary Statement Regarding Forward-Looking Statements.”

 

Risks Related to Our Business

 

We have a history of losses, may incur future losses and may not achieve profitability

 

BriaCell is a development stage immune-oncology biotechnology corporation that to date has not recorded any revenues from the sale of diagnostic or therapeutic products. Since incorporation, BriaCell has accumulated net losses and expects such losses to continue as it commences product and pre-clinical development and eventually enters into license agreements for its technology. We incurred net losses of $3,220,721, $5,412,663, $5,789,662 and $4,944,221 in the fiscal years ended July 31, 2017, 2018, 2019 and 2020, respectively. Management expects to continue to incur substantial operating losses unless and until such time as product sales generate sufficient revenues to fund continuing operations. BriaCell has neither a history of earnings nor has it paid any dividends and it is unlikely to pay dividends or enjoy earnings in the immediate or foreseeable future.

 

We are an early stage development company

 

The Company expects to spend a significant amount of capital to fund research and development. As a result, the Company expects that its operating expenses will increase significantly and, consequently, it will need to generate significant revenues to become profitable. Even if the Company does become profitable, it may not be able to sustain or increase profitability on a quarterly or annual basis. The Company cannot predict when, if ever, it will be profitable. There can be no assurances that the Intellectual Property of BriaCell, or other technologies it may acquire, will meet applicable regulatory standards, obtain required regulatory approvals, be capable of being produced in commercial quantities at reasonable costs, or be successfully marketed. The Company will be undertaking additional laboratory studies or trials with respect to the Intellectual Property of BriaCell, and there can be no assurance that the results from such studies or trials will result in a commercially viable product or will not identify unwanted side effects.

 

We have an unproven market for our product candidates

 

The Company believes that the anticipated market for its potential products and technologies if successfully developed will continue to exist and expand. These assumptions may prove to be incorrect for a variety of reasons, including competition from other products and the degree of commercial viability of the potential product.

 

We may not succeed in adapting to and meeting the business needs associated with our anticipated growth

 

Anticipated growth in all areas of BriaCell’s business is expected to continue to place a significant strain on its managerial, operational and technical resources. The Company expects operating expenses and staffing levels to increase in the future. To manage such growth, the Company must expand its operational and technical capabilities and manage its employee base while effectively administering multiple relationships with various third parties. There can be no assurance that the Company will be able to manage its expanding operations effectively. Any failure to implement cohesive management and operating systems, to add resources on a cost-effective basis or to properly manage the Company’s expansion could have a material adverse effect on its business and results of operations.

 

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We are heavily reliant on third-parties to carry out a large portion of our business

 

The Company does not expect to have any in-house manufacturing, pharmaceutical development or marketing capability. To be successful, a product must be manufactured and packaged in commercial quantities in compliance with regulatory requirements and in reasonable time frames and at accepted costs. The Company intends to contract with third parties to develop its products. No assurance can be given that the Company or its suppliers will be able to meet the supply requirements in respect of the product development or commercial sales.

 

Production of therapeutic products may require raw materials for which the sources and amount of supply are limited, or may be hindered by quality or scheduling issues in respect of the third party suppliers over which the Company has limited control. An inability to obtain adequate supplies of raw materials could significantly delay the development, regulatory approval and marketing of a product. The Company has limited in-house personnel to internally manage all aspects of product development, including the management of multi-center clinical trials. The Company is significantly reliant on third-party consultants and contractors to provide the requisite advice and management. There can be no assurance that the clinical trials and product development will not encounter delays which could adversely affect prospects for the Company’s success.

 

To be successful, an approved product must also be successfully marketed. The market for the Company’s product being developed by the Company may be large and will require substantial sales and marketing capability. At the present time, the Company does not have any internal capability to market pharmaceutical products. The Company intends to enter into one or more strategic partnerships or collaborative arrangements with pharmaceutical companies or other companies with marketing and distribution expertise to address this need. If necessary, the Company will establish arrangements with various partners for geographical areas. There can be no assurance that the Company can market, or can enter into a satisfactory arrangement with a third party to market a product in a manner that would assure its acceptance in the marketplace. However, if a satisfactory arrangement with a third party to market and/or distribute a product is obtained; the Company will be dependent on the corporate collaborator(s) who may not devote sufficient time, resources and attention to the Company’s programs, which may hinder efforts to market the products.

 

Should the Company not establish marketing and distribution strategic partnerships and collaborative arrangements on acceptable terms, and undertake some or all of those functions, the Company will require significant additional human and financial resources and expertise to undertake these activities, the availability of which is not guaranteed. The Company will rely on third parties for the timely supply of raw materials, equipment, contract manufacturing, and formulation or packaging services. Although the Company intends to manage these third-party relationships to ensure continuity and quality, some events beyond the Company’s control could result in complete or partial failure of these goods and services. Any such failure could have a material adverse effect on the financial conditions and result of operation of the Company

 

Due to the complexity of the process of developing pharmaceutical products, the Company’s business may depend on arrangements with pharmaceutical and biotechnology companies, corporate and academic collaborators, licensors, licensees and others for the research, development, clinical testing, technology rights, manufacturing, marketing and commercialization of its products. Such agreements could obligate the Company to diligently bring potential products to market, make milestone payments and royalties that, in some instances, could be substantial, and incur the costs of filing and prosecuting patent applications. There can be no assurance that the Company will be able to establish or maintain collaborations that are important to its business on favorable terms, or at all.

 

A number of risks arise from the Company’s potential dependence on collaborative agreements with third parties. Product development and commercialization efforts could be adversely affected if any collaborative partner terminates or suspends its agreement with the Company, causes delays, fails to on a timely basis develop or manufacture in adequate quantities a substance needed in order to conduct clinical trials, fails to adequately perform clinical trials, determines not to develop, manufacture or commercialize a product to which it has rights, or otherwise fails to meet its contractual obligations. The Company’s collaborative partners could pursue other technologies or develop alternative products that could compete with the products the Company is developing.

 

The Company has signed Non-Disclosure Agreements (“NDA”) with many different third parties as is customary in the industry. There is no guarantee that, despite the terms of the NDA which bind third parties, the Company will ultimately be able to prevent from such third parties from breaching their obligations under the NDA. Use of the Company’s confidential information in an unauthorized manner is likely to negatively affect the Company.

 

20
 

 

Pre-clinical studies and initial clinical trials are not necessarily predictive of future results

 

Pre-clinical tests and Phase I/II clinical trials are primarily designed to test safety, to study pharmacokinetics and pharmacodynamics and to understand the side effects of product candidates at various doses and schedules. Success in pre-clinical and early clinical trials does not ensure that later large-scale efficacy trials will be successful nor does it predict final results. Favorable results in early trials may not be repeated in later trials.

 

A number of companies in the life sciences industry have suffered significant setbacks in advanced clinical trials, even after positive results in earlier trials. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. Negative or inconclusive results or adverse medical events during a clinical trial could cause a clinical trial to be delayed, repeated or terminated. Any pre-clinical data and the clinical results obtained for BriaCell’s technology may not predict results from studies in larger numbers of subjects drawn from more diverse populations or in the commercial setting, and also may not predict the ability of our products to achieve their intended goals, or to do so safely.

 

An inability to obtain raw materials or product supply could have a material adverse impact on the Company’s business, financial condition and results of operations

 

Raw materials and supplies are generally available in quantities to meet the needs of the Company’s business. The Company will be dependent on third-party manufacturers for the pharmaceutical products that it markets. An inability to obtain raw materials or product supply could have a material adverse impact on the Company’s business, financial condition and results of operations.

 

We must obtain additional capital to continue our operations

 

The Company anticipates that additional capital will be required to complete its current research and development programs. It is anticipated that future research, additional pre-clinical and toxicology studies and manufacturing initiatives, including that to prepare for market approval and successful product market launch will require additional funds. Further financing may dilute the current holdings of shareholders and may thereby result in a loss for the shareholders. There can be no assurance that the Company will be able to obtain adequate financing, or financing on terms that are reasonable or acceptable for these or other purposes, or to fulfill the Company’s obligations under various license agreements. Failure to obtain such additional financing could result in delay or indefinite postponement of further research and development of the Company’s technologies with the possible loss of license rights to these technologies.

 

Although the Company’s common shares are quoted or listed for trading on the OTCQB and TSXV, there can be no assurance that a liquid market for our common shares will develop, which may have an adverse effect on the market price of the Company’s common shares.

 

We are highly dependent on our key personnel

 

Although the Company is expected to have experienced senior management and personnel, the Company will be substantially dependent upon the services of a few key personnel, particularly Dr. Charles Wiseman and Dr. William V. Williams and other professionals for the successful operation of its business. Phase I of the Company’s research and development is planned to be completed by qualified professionals and is expected to concentrate on treatment of advanced breast cancer. The loss of the services of any of these personnel could have a material adverse effect on the business of the Company. The Company may not be able to attract and retain personnel on acceptable terms given the intense competition for such personnel among high technology enterprises, including biotechnology, and healthcare companies, universities and non-profit research institutions. If we lose any of these persons, or are unable to attract and retain qualified personnel, our business, financial condition and results of operations may be materially and adversely affected.

 

21
 

 

If the Company experiences a data security breach and confidential information is disclosed, the Company may be subject to penalties and experience negative publicity

 

The Company and its customers could suffer harm if personal and health information were accessed by third parties due to a system security failure. The collection of data requires the Company to receive and store a large amount of personally identifiable data. Recently, data security breaches suffered by well-known companies and institutions have attracted a substantial amount of media attention, prompting legislative proposals addressing data privacy and security. The Company may become exposed to potential liabilities with respect to the data that it collects, manages and processes, and may incur legal costs if information security policies and procedures are not effective or if the Company is required to defend its methods of collection, processing and storage of personal data. Future investigations, lawsuits or adverse publicity relating to its methods of handling such information could have a material adverse effect on the Company’s business, financial condition and results of operations due to the costs and negative market reaction relating to such developments.

 

The report of our independent registered public accounting firm expresses substantial doubt about our ability to continue as a going concern

 

Our independent registered public accounting firm indicated in its report on our financial statements for the year ended July 31, 2020, that conditions exist that raise substantial doubt about our ability to continue as a “going concern.”   A going concern paragraph included in our independent registered public accounting firm’s report on our consolidated financial statements could impair investor perceptions and our ability to finance our operations through the sale of equity, incurring debt, or other financing alternatives. Our ability to continue as a going concern will depend upon many factors beyond our control including the availability and terms of future funding. If we are unable to achieve our goals and raise the necessary funds to finance our operations, our business would be jeopardized, and we may not be able to continue. If we ceased operations, it is likely that all of our investors would lose their investment.

 

We may not succeed in completing the development of our products, commercializing our products or generating significant revenues

 

Since commencing our operations, we have focused on the research and development and limited clinical trials of our product candidates. Our ability to generate revenues and achieve profitability depends on our ability to successfully complete the development of our products, obtain market approval and generate significant revenues. The future success of our business cannot be determined at this time, and we do not anticipate generating revenues from product sales for the foreseeable future. In addition, we face a number of challenges with respect to our future commercialization efforts, including, among others, that:

 

  we may not have adequate financial or other resources to complete the development of our product, including two stages of clinical development that are necessary in order to commercialize our products;
     
  we may not be able to manufacture our products in commercial quantities, at an adequate quality or at an acceptable cost;
     
  we may not be able to maintain our CE mark due to the regulatory changes;
     
  we may never receive FDA approval for our intended development plans;
     
  we may not be able to establish adequate sales, marketing and distribution channels;
     
  healthcare professionals and patients may not accept our product candidates;
     
  technological breakthroughs in cancer detection, treatment and prevention may reduce the demand for our product candidates;
     
  changes in the market for cancer treatment, new alliances between existing market participants and the entrance of new market participants may interfere with our market penetration efforts;

 

22
 

 

  third-party payors may not agree to reimburse patients for any or all of the purchase price of our products, which may adversely affect patients’ willingness to purchase our product candidates;
     
  uncertainty as to market demand may result in inefficient pricing of our product candidates;
     
  we may face third-party claims of intellectual property infringement;
     
  we may fail to obtain or maintain regulatory approvals for our products candidates in our target markets or may face adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; and
     
  we are dependent upon the results of ongoing clinical studies relating to our product candidates and the products of our competitors. We may fail in obtaining positive results.

 

If we are unable to meet any one or more of these challenges successfully, our ability to effectively commercialize our product candidates could be limited, which in turn could have a material adverse effect on our business, financial condition and results of operations.

 

If product liability lawsuits are brought against us, we may incur substantial liabilities and the commercialization of our drug candidates may be affected

 

As our drug candidates enter clinical trials, we will face an inherent risk of product liability suits and will face an even greater risk if we obtain approval to commercialize any drugs. For example, we may be sued if our drug candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the drug, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our drug candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

 

  decreased demand for our drugs;
     
  injury to our reputation;
     
  withdrawal of clinical trial participants and inability to continue clinical trials;
     
  initiation of investigations by regulators;
     
  costs to defend the related litigation;
     
  a diversion of management’s time and our resources;
     
  substantial monetary awards to trial participants or patients;
     
  product recalls, withdrawals or labeling, marketing or promotional restrictions;
     
  loss of revenue;
     
  exhaustion of any available insurance and our capital resources;
     
  the inability to commercialize any drug candidate; and
     
  a decline in the price of our common shares.

 

23
 

 

We shall seek to obtain the appropriate insurance once our candidates are ready for clinical trial. However, our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of drugs we develop, alone or with collaborators. We currently do not have in place product liability insurance and although we plan to have in place such insurance as and when the products are ready for commercialization, as well as insurance covering clinical trials, the amount of such insurance coverage may not be adequate, we may be unable to maintain such insurance, or we may not be able to obtain additional or replacement insurance at a reasonable cost, if at all. Our insurance policies may also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise.

 

Additionally, we may be sued if the products that we commercialize, market or sell cause or are perceived to cause injury or are found to be otherwise unsuitable, and may result in:

 

  decreased demand for those products;
     
  damage to our reputation;
     
  costs incurred related to product recalls;
     
  limiting our opportunities to enter into future commercial partnership; and
     
  a decline in the price of our common shares.

 

We face business disruption and related risks resulting from the recent outbreak of the novel coronavirus 2019 (COVID-19), which could have a material adverse effect on our business plan.

 

The development of our product candidates could be disrupted and materially adversely affected by the recent outbreak of COVID-19. As a result of measures imposed by the governments in affected regions, businesses and schools have been suspended due to quarantines intended to contain this outbreak. The spread of COVID-19 from China to other countries has resulted in the Director General of the World Health Organization declaring the outbreak of COVID-19 as a Public Health Emergency of International Concern (PHEIC), based on the advice of the Emergency Committee under the International Health Regulations (2005), and the Centers for Disease Control and Prevention in the U.S. issued a warning on February 25, 2020 regarding the likely spread of COVID-19 to the U.S. While the COVID-19 outbreak is still in the early stages, international stock markets have begun to reflect the uncertainty associated with the slow-down in the Chinese economy and the reduced levels of international travel experienced since the beginning of January and the significant declines in the Dow Industrial Average during 2020 was largely attributed to the effects of COVID-19. We have enrolled, and will seek to enroll, cancer patients in our clinical trials. In the event that clinical trial sites are slowed down or closed to enrollment in our trials, this could have a material adverse impact on our clinical trial plans and timelines. We may face difficulties recruiting or retaining patients in our ongoing and planned clinical trials if patients are affected by the virus or are fearful of visiting or traveling to our clinical trial sites because of the outbreak. We are continuing to assess our business plans and the impact COVID-19 is having on our clinical trial timelines and our ability to recruit candidates for clinical trials, but there can be no assurance that this analysis will enable us to avoid part or all of any impact from the spread of COVID-19 or its consequences, including downturns in business sentiment generally or in our sector in particular. The extent to which COVID-19 and global efforts to contain its spread will impact our operations will depend on future developments, which are highly uncertain and cannot be predicted at this time, and include the duration, severity and scope of the outbreak and the actions taken to contain or treat the coronavirus outbreak. We currently believe that the execution of our clinical trials and research programs are delayed by at least one quarter due to COVID-19.

 

Risks Related to Our Intellectual Property

 

We may not successfully develop, maintain and protect our proprietary products and technologies

 

BriaCell’s success depends to a significant degree upon its ability to develop, maintain and protect proprietary products and technologies. BriaCell files patent applications in the United States and other countries as part of its global strategy to protect its Intellectual Property and maintains certain US and Non-US patents in its IP portfolio. However, patents provide only limited protection of BriaCell’s Intellectual Property. The assertion of patent protection involves complex legal and factual determinations and is therefore uncertain and can be expensive. BriaCell cannot provide assurances that patents will be granted with respect to any of its pending patent applications, or that the scope of any of its granted patents, or any patents granted in the future, will be sufficiently broad to offer meaningful protection, or that it will develop and file patent applications on additional proprietary technologies that are patentable, or, if patentable, that any patents will be granted from such patent applications. BriaCell’s current or future patents could be successfully challenged, invalidated or circumvented. This could result in BriaCell’s patent rights failing to create an effective competitive barrier. Losing a significant patent or failing to get a patent to issue from a pending patent application that BriaCell considers significant could have a material adverse effect on BriaCell’s business. The laws governing the scope of patent coverage in various countries continue to evolve. The laws of some foreign countries may not protect BriaCell’s Intellectual Property rights to the same extent as the laws of the United States. BriaCell has applied for patent protection only in selected countries. Therefore, third parties may be able to replicate BriaCell technologies covered by BriaCell’s patent portfolio in countries in which it does not have patent protection.

 

BriaCell’s future success and competitive position depends in part upon its ability to maintain its Intellectual Property portfolio. There can be no assurance that any patents will be issued on any existing or future patent applications.

 

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We are susceptible to intellectual property suits that could cause us to incur substantial costs or pay substantial damages or prohibit us from selling our product candidates

 

There is a substantial amount of litigation over patent and other Intellectual Property rights in the biotechnology industry. Whether or not a product infringes a patent involves complex legal and factual considerations, the determination of which is often uncertain. Our management is presently unaware of any other parties’ patents and proprietary rights which our products under development would infringe. Searches typically performed to identify potentially infringed patents of third parties are often not conclusive and, because patent applications can take many years to issue, there may be applications now pending, which may later result in issued patents which our current or future products may infringe or be alleged to infringe. In addition, our competitors or other parties may assert that our product candidates and the methods employed may be covered by patents held by them. If any of our products infringes a valid patent, we could be prevented from manufacturing or selling such product unless we are able to obtain a license or able to redesign the product in such a manner as to avoid infringement. A license may not always be available or may require us to pay substantial royalties. We also may not be successful in any attempt to redesign our product to avoid infringement, nor does a later redesign protect BriaCell from prior infringement. Infringement and other Intellectual Property claims, with or without merit, can be expensive and time-consuming to litigate and can divert our management’s attention from operating our business.

 

The steps we have taken to protect our Intellectual Property may not be adequate, which could have a material adverse effect on our ability to compete in the market

 

BriaCell’s ability to establish and maintain a competitive position may be achieved in part by prosecuting claims against others who it believes to be infringing its rights. In addition, enforcement of BriaCell’s patents in foreign jurisdictions will depend on the legal procedures in those jurisdictions. In addition to filing patent applications, we rely on confidentiality, non-compete, non-disclosure and assignment of inventions provisions, as appropriate, in our agreements with our employees, consultants, and service providers, to protect and otherwise seek to control access to, and distribution of, our proprietary information. These measures may not be adequate to protect our Intellectual Property from unauthorized disclosure, third-party infringement or misappropriation, for the following reasons:

 

  the agreements may be breached, may not provide the scope of protection we believe they provide or may be determined to be unenforceable;
     
  we may have inadequate remedies for any breach;
     
  proprietary information could be disclosed to our competitors; or
     
  others may independently develop substantially equivalent or superior proprietary information and techniques or otherwise gain access to our trade secrets or disclose such technologies.

 

Specifically, with respect to non-compete agreements, both state law and precedent varies greatly from state to state and we may be unable to enforce these agreements, in whole or in part, and it may be difficult for us to restrict our competitors from gaining the expertise that our former employees gained while working for us. If our Intellectual Property is disclosed or misappropriated, it could harm our ability to protect our rights and could have a material adverse effect on our business, financial condition and results of operations.

 

We may need to initiate lawsuits to protect or enforce our patents and other Intellectual Property rights, which could be expensive and, if we lose, could cause us to lose some of our Intellectual Property rights, which would harm our ability to compete in the market

 

We rely on patents, confidentiality and trade secrets to protect a portion of our Intellectual Property and our competitive position. Patent law relating to the scope of claims in the technology fields in which we operate is still evolving and, consequently, patent positions in the biotechnology/pharmaceutical industry can be uncertain. In order to protect or enforce our patent rights, we may initiate patent and related litigation against third parties, such as infringement suits or requests for injunctive relief. BriaCell’s ability to establish and maintain a competitive position may be achieved in part by prosecuting claims against others who it believes to be infringing its rights. In addition, enforcement of BriaCell’s patents in foreign jurisdictions will depend on the legal procedures in those jurisdictions. Any lawsuits that we initiate could be expensive, take significant time and divert our management’s attention from other business concerns and the outcome of litigation to enforce our Intellectual Property rights in patents, copyrights, trade secrets or trademarks is highly unpredictable. Litigation also puts our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, or adversely affect its ability to distribute any products that are subject to such litigation. In addition, we may provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, including attorney fees, if any, may not be commercially valuable. The occurrence of any of these events could have a material adverse effect on our business, financial condition and results of operations.

 

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We may be subject to damages resulting from claims that we or our employees or contractors have wrongfully used or disclosed alleged trade secrets of their former employers

 

Many of our employees and contractors were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that we or any employee or contractor has inadvertently or otherwise used or disclosed trade secrets or other proprietary information of his or her former employers. Litigation may be necessary to defend against these claims. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable Intellectual Property rights or personnel. A loss of key research personnel or their work product could hamper or prevent our ability to commercialize certain therapeutic candidates, which could severely harm our business, financial condition and results of operations. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

 

If the FDA or comparable foreign regulatory authorities approve generic versions of any of our products that receive marketing approval, or such authorities do not grant our products appropriate periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected.

 

Once a new drug application is approved, the product covered thereby becomes a “reference listed drug” in the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. Manufacturers may seek approval of generic versions of reference listed drugs through submission of abbreviated new drug applications in the United States. In support of an abbreviated new drug applications, a generic manufacturer need not conduct clinical trials. Rather, the applicant generally must show that its product has the same active ingredient(s), dosage form, strength, route of administration and conditions of use or labeling as the reference listed drug and that the generic version is bioequivalent to the reference listed drug, meaning it is absorbed in the body at the same rate and to the same extent. Generic products may be significantly less costly to bring to market than the reference listed drug and companies that produce generic products are generally able to offer them at lower prices. Thus, following the introduction of a generic drug, a significant percentage of the sales of any branded product or reference listed drug is typically lost to the generic product.

 

The FDA may not approve abbreviated new drug applications for a generic product until any applicable period of non-patent exclusivity for the reference listed drug has expired. The United States Federal Food, Drug, and Cosmetic Act provides a period of five years of non-patent exclusivity for a new drug containing a new chemical entity (“NCE”). Specifically, in cases where such exclusivity has been granted, abbreviated new drug applications may not be submitted to the FDA until the expiration of five years unless the submission is accompanied by a Paragraph IV certification that a patent covering the reference listed drug is either invalid or will not be infringed by the generic product, in which case the applicant may submit its application four years following approval of the reference listed drug.

 

While we believe that our products contain active ingredients that would be treated as NCEs by the FDA and, therefore, if approved, should be afforded five years of data exclusivity, the FDA may disagree with that conclusion and may approve generic products after a period that is less than five years. If the FDA were to award NCE exclusivity to someone other than us, we believe that we would still be awarded three year “Other” exclusivity protection from generic competition, which is awarded when an application or supplement contains reports of new clinical investigations (not bioavailability studies) conducted or sponsored by an applicant and essential for approval. Manufacturers may seek to launch these generic products following the expiration of the applicable marketing exclusivity period, even if we still have patent protection for our product. If we do not maintain patent protection and data exclusivity for our product candidates, our business may be materially harmed.

 

Competition that our products may face from generic versions of our products could materially and adversely impact our future revenue, profitability and cash flows and substantially limit our ability to obtain a return on the investments we have made in those product candidates.

 

Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.

 

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest United States non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to competition from competitive products, including generics or biosimilars. Given the amount of time required for the development, testing, and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

 

Risks Related to Regulations

 

Changes in legislation and regulations may affect our revenue and profitability

 

Existing and proposed changes in the laws and regulations affecting public companies may cause the Company to incur increased costs as the Company evaluates the implications of new rules and responds to new requirements. Failure to comply with new rules and regulations could result in enforcement actions or the assessment of other penalties. New laws and regulations could make it more difficult to obtain certain types of insurance, including director’s and officer’s liability insurance, and the Company may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage, to the extent that such coverage remains available.

 

The impact of these events could also make it more difficult for the Company to attract and retain qualified persons to serve on the Board, or as executive officers. The Company may be required to hire additional personnel and utilize additional outside legal, accounting and advisory services, all of which could cause the Company’s general and administrative costs to increase beyond what the Company currently has planned. Although the Company evaluates and monitors developments with respect to new rules and laws, the Company cannot predict or estimate the amount of the additional costs the Company may incur or the timing of such costs with respect to such evaluations and/or compliance and cannot provide assurances that such additional costs will render the Company compliant with such new rules and laws.

 

If we or our licensees are unable to obtain U.S., Canadian and/or foreign regulatory approval for our product candidates, we will be unable to commercialize our therapeutic candidates

 

To date, we have not marketed, distributed or sold an approved product. Our therapeutic candidates are subject to extensive governmental regulations relating to development, clinical trials, manufacturing and commercialization of drugs. We may not obtain marketing approval for any of our therapeutic candidates in a timely manner or at all. In connection with the clinical trials for our product candidates and other therapeutic candidates that we may seek to develop in the future, either on our own or throughout licensing arrangements, we face the risk that:

 

  a product candidate may not prove safe or efficacious;
     
  the results with respect to any product candidate may not confirm the positive results from earlier preclinical studies or clinical trials;
     
  the results may not meet the level of statistical significance required by the FDA, Health Canada or other regulatory authorities; and
     
  the results will justify only limited and/or restrictive uses, including the inclusion of warnings and contraindications, which could significantly limit the marketability and profitability of the therapeutic candidate.

 

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Any delay in obtaining, or the failure to obtain, required regulatory approvals will materially and adversely affect our ability to generate future revenues from a particular product candidate. Any regulatory approval to market a product may be subject to limitations on the indicated uses for which we may market the product or may impose restrictive conditions of use, including cautionary information, thereby limiting the size of the market for the product. We and our licensees, as applicable, also are, and will be, subject to numerous foreign regulatory requirements that govern the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process includes all of the risks associated with the FDA approval process that we describe above, as well as risks attributable to the satisfaction of foreign requirements. Approval by the FDA does not ensure approval by regulatory authorities outside the United States. Foreign jurisdictions may have different approval processes than those required by the FDA and may impose additional testing requirements for our therapeutic candidates.

 

If the third parties on which we rely to conduct our clinical trials and clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory clearance or approval for, or commercialize, our product candidates

 

We do not have the ability to independently conduct our clinical trials for our product candidates and we must rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct such trials. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory clearance for, or successfully commercialize, our product candidates on a timely basis, if at all, and our business, operating results and prospects may be adversely affected. Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside of their control.

 

Modifications to our product candidates, or to any other product candidates that we may develop in the future, may require new regulatory clearances or approvals or may require us or our licensees, as applicable, to recall or cease marketing these therapeutic candidates until clearances are obtained

 

Modifications to our product candidates, after they have been approved for marketing, if at all, or to any other pharmaceutical product that we may develop in the future, may require new regulatory clearance, or approvals, and, if necessitated by a problem with a marketed product, may result in the recall or suspension of marketing of the previously approved and marketed product until clearances or approvals of the modified product are obtained. The FDA requires pharmaceutical products manufacturers to initially make and document a determination of whether or not a modification requires a new approval, supplement or clearance. A manufacturer may determine in conformity with applicable regulations and guidelines that a modification may be implemented without pre-clearance by the FDA; however, the FDA can review a manufacturer’s decision and may disagree. The FDA may also on its own initiative determine that a new clearance or approval is required. If the FDA requires new clearances or approvals of any pharmaceutical product or medical device for which we or our licensees receive marketing approval, if any, we or our licensees may be required to recall such product and to stop marketing the product as modified, which could require us or our licensees to redesign the product and will have a material adverse effect on our business, financial condition and results of operations. In these circumstances, we may be subject to significant enforcement actions.

 

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The results of our clinical trials may not support our product claims or may result in the discovery of adverse side effects

 

Even if our clinical trials are completed as planned, we cannot be certain that their results will support our product claims or that any regulatory authority whose approval we will require in order to market and sell our products in any territory will agree with our conclusions regarding them. Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that clinical trials will replicate the results of prior trials and pre-clinical studies. The clinical trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses, which could cause us to abandon a product and may delay development of others. Any delay or termination of our clinical trials will delay the filing of our regulatory submissions and, ultimately, our ability to commercialize our product candidates and generate revenues. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.

 

Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results

 

We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including FDA approval. Clinical trials are expensive and complex, can take many years and have uncertain outcomes. We cannot predict whether we or our licensees will encounter problems with any of the completed, ongoing or planned clinical trials that will cause us, our licensees or regulatory authorities to delay or suspend clinical trials, or delay the analysis of data from completed or ongoing clinical trials. We estimate that clinical trials of our most advanced therapeutic candidates will continue for several years, but they may take significantly longer to complete. Failure can occur at any stage of the testing and we may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent commercialization of our current or future therapeutic candidates, including but not limited to:

 

  delays in securing clinical investigators or trial sites for the clinical trials;
     
  delays in obtaining institutional review board and other regulatory approvals to commence a clinical trial;
     
  slower than anticipated patient recruitment and enrollment;
     
  negative or inconclusive results from clinical trials;
     
  unforeseen safety issues;
     
  uncertain dosing issues;
     
  an inability to monitor patients adequately during or after treatment; and
     
  problems with investigator or patient compliance with the trial protocols.

 

A number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience than us, have suffered significant setbacks in advanced clinical trials, even after seeing promising results in earlier clinical trials. Despite the results reported in earlier clinical trials for our therapeutic candidates, we do not know whether any phase 3 or other clinical trials we or our licensees may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market our therapeutic candidates. If later-stage clinical trials of any therapeutic candidate do not produce favorable results, our ability to obtain regulatory approval for the therapeutic candidate may be adversely impacted, which will have a material adverse effect on our business, financial condition and results of operations.

 

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The pharmaceutical business is subject to increasing government price controls and other restrictions on pricing, reimbursement and access to drugs, which could adversely affect our future revenues and profitability

 

To the extent our products are developed, commercialized, and successfully introduced to market, they may not be considered cost-effective and third-party or government reimbursement might not be available or sufficient. Globally, governmental and other third-party payors are becoming increasingly aggressive in attempting to contain health care costs by strictly controlling, directly or indirectly, pricing and reimbursement and, in some cases, limiting or denying coverage altogether on the basis of a variety of justifications, and we expect pressures on pricing and reimbursement from both governments and private payors inside and outside the U.S. to continue.

 

In the U.S., we are subject to substantial pricing, reimbursement, and access pressures from state Medicaid programs, private insurance programs and pharmacy benefit managers, and implementation of U.S. health care reform legislation is increasing these pricing pressures. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively, the “PPACA” or the “Affordable Care Act”), instituted comprehensive health care reform, and includes provisions that, among other things, reduce and/or limit Medicare reimbursement, require all individuals to have health insurance (with limited exceptions), and impose new and/or increased taxes. The future of the Affordable Care Act and its constituent parts are uncertain at this time.

 

In almost all markets, pricing and choice of prescription pharmaceuticals are subject to governmental control. Therefore, the price of our products and their reimbursement in Europe and in other countries is and will be determined by national regulatory authorities. Reimbursement decisions from one or more of the European markets may impact reimbursement decisions in other European markets. A variety of factors are considered in making reimbursement decisions, including whether there is sufficient evidence to show that treatment with the product is more effective than current treatments, that the product represents good value for money for the health service it provides, and that treatment with the product works at least as well as currently available treatments.

 

The continuing efforts of government and insurance companies, health maintenance organizations, and other payors of health care costs to contain or reduce costs of health care may affect our future revenues and profitability or those of our potential customers, suppliers, and collaborative partners, as well as the availability of capital.

 

United States federal and state privacy laws, and equivalent laws of other nations, may increase our costs of operation and expose us to civil and criminal sanctions

 

The Health Insurance Portability and Accountability Act of 1996, as amended, and the regulations that have been issued under it, or collectively HIPAA, and similar laws outside the United States, contain substantial restrictions and requirements with respect to the use and disclosure of individuals’ protected health information. The HIPAA privacy rules prohibit “covered entities,” such as healthcare providers and health plans, from using or disclosing an individual’s protected health information, unless the use or disclosure is authorized by the individual or is specifically required or permitted under the privacy rules. Under the HIPAA security rules, covered entities must establish administrative, physical and technical safeguards to protect the confidentiality, integrity and availability of electronic protected health information maintained or transmitted by them or by others on their behalf. While we do not believe that we will be a covered entity under HIPAA, we believe many of our customers will be covered entities subject to HIPAA. Such customers may require us to enter into business associate agreements, which will obligate us to safeguard certain health information we obtain in the course of our relationship with them, restrict the manner in which we use and disclose such information and impose liability on us for failure to meet our contractual obligations.

 

In addition, under The Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, which was signed into law as part of the U.S. stimulus package in February 2009, certain of HIPAA’s privacy and security requirements are now also directly applicable to “business associates” of covered entities and subject them to direct governmental enforcement for failure to comply with these requirements. We may be deemed as a “business associate” of some of our customers. As a result, we may be subject as a “business associate” to civil and criminal penalties for failure to comply with applicable privacy and security rule requirements. Moreover, HITECH created a new requirement obligating “business associates” to report any breach of unsecured, individually identifiable health information to their covered entity customers and imposes penalties for failing to do so.

 

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In addition to HIPAA, most U.S. states have enacted patient confidentiality laws that protect against the disclosure of confidential medical information, and many U.S. states have adopted or are considering adopting further legislation in this area, including privacy safeguards, security standards, and data security breach notification requirements. These U.S. state laws, which may be even more stringent than the HIPAA requirements, are not preempted by the federal requirements, and we are therefore required to comply with them to the extent they are applicable to our operations.

 

These and other possible changes to HIPAA or other U.S. federal or state laws or regulations, or comparable laws and regulations in countries where we conduct business, could affect our business and the costs of compliance could be significant. Failure by us to comply with any of the standards regarding patient privacy, identity theft prevention and detection, and data security may subject us to penalties, including civil monetary penalties and in some circumstances, criminal penalties. In addition, such failure may damage our reputation and adversely affect our ability to retain customers and attract new customers.

 

The protection of personal data, particularly patient data, is subject to strict laws and regulations in many countries. The collection and use of personal health data in the EU is governed by the provisions of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, commonly known as the Data Protection Directive. The Directive imposes a number of requirements including an obligation to seek the consent of individuals to whom the personal data relates, the information that must be provided to the individuals, notification of data processing obligations to the competent national data protection authorities of individual EU Member States and the security and confidentiality of the personal data. The Data Protection Directive also imposes strict rules on the transfer of personal data out of the EU to the U.S. Failure to comply with the requirements of the Data Protection Directive and the related national data protection laws of the EU Member States may result in fines and other administrative penalties and harm our business. We may incur extensive costs in ensuring compliance with these laws and regulations, particularly if we are considered to be a data controller within the meaning of the Data Protection Directive.

 

If we fail to comply with the U.S. federal Anti-Kickback Statute and similar state and foreign country laws, we could be subject to criminal and civil penalties and exclusion from federally funded healthcare programs including the Medicare and Medicaid programs and equivalent third country programs, which would have a material adverse effect on our business and results of operations

 

A provision of the Social Security Act, commonly referred to as the federal Anti-Kickback Statute, prohibits the knowing and willful offer, payment, solicitation or receipt of any form of remuneration, directly or indirectly, in cash or in kind, to induce or reward the referring, ordering, leasing, purchasing or arranging for, or recommending the ordering, purchasing or leasing of, items or services payable, in whole or in part, by Medicare, Medicaid or any other federal healthcare program. Although there are a number of statutory exemptions and regulatory safe harbors to the federal Anti-Kickback Statute protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exemptions and safe harbors are drawn narrowly, and practices that do not fit squarely within an exemption or safe harbor may be subject to scrutiny. The federal Anti-Kickback Statute is very broad in scope and many of its provisions have not been uniformly or definitively interpreted by existing case law or regulations. In addition, most of the states have adopted laws similar to the federal Anti-Kickback Statute, and some of these laws are even broader than the federal Anti-Kickback Statute in that their prohibitions may apply to items or services reimbursed under Medicaid and other state programs or, in several states, apply regardless of the source of payment. Violations of the federal Anti-Kickback Statute may result in substantial criminal, civil or administrative penalties, damages, fines and exclusion from participation in federal healthcare programs.

 

All of our future financial relationships with U.S. healthcare providers, purchasers, formulary managers, and others who provide products or services to federal healthcare program beneficiaries will potentially be governed by the federal Anti-Kickback Statute and similar state laws. We believe our operations will be in compliance with the federal Anti-Kickback Statute and similar state laws. However, we cannot be certain that we will not be subject to investigations or litigation alleging violations of these laws, which could be time-consuming and costly to us and could divert management’s attention from operating our business, which in turn could have a material adverse effect on our business. In addition, if our arrangements were found to violate the federal Anti-Kickback Statute or similar state laws, the consequences of such violations would likely have a material adverse effect on our business, results of operations and financial condition.

 

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There are other federal and state laws that may affect our ability to operate, including the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government. Moreover, we may be subject to other federal false claim laws, including, among others, federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs. Moreover, there are analogous state laws. Violations of these laws can result in substantial criminal, civil or administrative penalties, damages, fines and exclusion from participation in federal healthcare programs.

 

Moreover, the provisions of the Foreign Corrupt Practices Act of 1997 and other similar anti-bribery laws in other jurisdictions generally prohibit companies and their intermediaries from providing money or anything of value to officials of foreign governments, foreign political parties, or international organizations with the intent to obtain or retain business or seek a business advantage. Recently, there has been a substantial increase in anti-bribery law enforcement activity by U.S. regulators, with more aggressive and frequent investigations and enforcement by both the SEC and the Department of Justice. A determination that our operations or activities violated U.S. or foreign laws or regulations could result in imposition of substantial fines, interruption of business, loss of supplier, vendor or other third-party relationships, termination of necessary licenses and permits, and other legal or equitable sanctions. In addition, lawsuits brought by private litigants may also follow as a consequence.

 

Risks Related to Our Securities and this Offering

 

An active trading market for our common shares and Warrants may not develop on Nasdaq and our securityholders may not be able to resell their common shares or Warrants

 

Our common shares are quoted on the OTCQB and listed on the TSXV and Frankfurt Stock Exchange and an active trading market for our common shares has developed on the TSXV but has not developed on the OTCQB or on the Frankfurt Stock Exchange. We are in the process of applying to have our common shares and Warrants listed on the Nasdaq Capital Market but an active trading market for our shares or Warrants may never develop or be sustained following this offering. We cannot predict the extent to which an active market for our common shares or Warrants will develop or be sustained after the listing of such securities on Nasdaq. If an active trading market for our common shares or Warrants does not develop after this offering, the market price and liquidity of our common shares or Warrants may be materially and adversely affected.

 

There is no public market for the Pre-Funded Warrants being offered by us in this offering

 

There is no established public trading market for the Pre-Funded Warrants being offered in this offering, and we do not expect a market to develop. In addition, we do not intend to apply to list the Pre-Funded Warrants on any national securities exchange or other nationally recognized trading system, including Nasdaq or the TSXV. Without an active market, the liquidity of the Pre-Funded Warrants will be limited.

 

The Warrants may not have any value

 

The Warrants will be exercisable for five years from the date of initial issuance at an initial exercise price equal to 125% of the public offering price per unit set forth on the cover page of this prospectus. There can be no assurance that the market price of the common shares will ever equal or exceed the exercise price of the Warrants. In the event that the share price of our common shares does not exceed the exercise price of the Warrants during the period when the Warrants are exercisable, the Warrants may not have any value.

 

Holders of Pre-funded Warrants and Warrants purchased in this offering will have no rights as common shareholders until such holders exercise their Pre-funded Warrants or Warrants and acquire our common shares

 

Until holders of Pre-funded Warrants or Warrants acquire common shares stock upon exercise thereof, such holders will have no rights with respect to the common shares underlying the Pre-funded Warrants and the Warrants. Upon exercise of the Pre-funded Warrants or Warrants, the holders will be entitled to exercise the rights of a common shareholder only as to matters for which the record date occurs after the exercise date.

 

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Future issuance of our common shares could dilute the interests of existing shareholders

 

We may issue additional common shares in the future. The issuance of a substantial number of common shares could have the effect of substantially diluting the interests of our shareholders. In addition, the sale of a substantial amount of common shares in the public market, in the initial issuance, in a situation in which we acquire a company and the acquired company receives common shares as consideration and the acquired company subsequently sells its common shares, or by investors who acquired such common shares in a private placement, could have an adverse effect on the market price of our common shares.

 

We have a significant number of options and warrants outstanding, and while these options and warrants are outstanding, it may be more difficult to raise additional equity capital

 

As of December 10, 2020, 2020, we had outstanding options and warrants to purchase 285,360 common shares, respectively. The holders of these options and warrants are given the opportunity to profit from a rise in the market price of our common shares. We may find it more difficult to raise additional equity capital while these options and warrants are outstanding. At any time during which these warrants are likely to be exercised, we may be unable to obtain additional equity capital on more favorable terms from other sources. Additionally, the exercise of these options and warrants will cause the increase of our outstanding Common shares, which could have the effect of substantially diluting the interests of our current shareholders.

 

Sales of a substantial number of our common shares in the public market by our existing shareholders could cause our share price to fall

 

Sales of a substantial number of our common shares in the public market, or the perception that these sales might occur, could depress the market price of our common shares and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that sales may have on the prevailing market price of our common shares. All of the shares owned by our directors and officers are subject to lock-up agreements with the underwriters of this offering that restrict such shareholders’ ability to transfer our common shares for at least six months from the date of this offering. All of our outstanding shares held by our directors and officers will become eligible for unrestricted sale upon expiration of the lockup period. In addition, shares issued or issuable upon exercise of options and warrants vested as of the expiration of the lock-up period will be eligible for sale at that time. Sales of shares by these shareholders could have a material adverse effect on the trading price of our common shares. We intend to register the offering, issuance, and sale of all common shares that we may issue under our equity compensation plans. Once we register these shares, they can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates and the lock-up agreements.

 

We are an Emerging Growth Company, which may reduce the amount of information available to investors

 

The Jumpstart Our Business Start-ups Act, or the JOBS Act, and our status as a foreign private issuer will allow us to postpone the date by which we must comply with some of the laws and regulations intended to protect investors and to reduce the amount of information we provide in our reports filed with the SEC, which could undermine investor confidence in our company and adversely affect the market price of our Common shares.

 

For as long as we remain an “emerging growth company” as defined in the JOBS Act, we intend to take advantage of certain exemptions from various requirements that are applicable to public companies that are not emerging growth companies including:

 

  the provisions of the Sarbanes-Oxley Act requiring that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting;
     
  any rules that may be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement to the auditor’s report on the financial statements.

 

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We intend to take advantage of these exemptions until we are no longer an “emerging growth company.” We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year of the fifth anniversary of the consummation of this offering, (b) in which we have total annual gross revenue of at least US$ 1.07 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our Common shares that is held by non-affiliates exceeds US$ 700 million as of the prior June 30, and (2) the date on which we have issued more than US$ 1.0 billion in non-convertible debt during the prior three-year period.

 

We cannot predict if investors will find our common shares or Warrants less attractive because we may rely on these exemptions. If some investors find our common shares or Warrants less attractive as a result, there may be a less active trading market for our common shares or Warrants, and our common share or Warrant price may be more volatile and may decline.

 

We are a foreign private issuer and, as a result, we are not subject to U.S. proxy rules and are subject to reporting obligations that, to some extent, are more lenient and less frequent than those applicable to a U.S. issuer

 

Because we qualify as a foreign private issuer under the Exchange Act, we are exempt from certain provisions of the Exchange Act that are applicable to U.S. publicly reporting companies, including (i) the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act, (ii) the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time, and (iii) the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information, or current reports on Form 8-K, upon the occurrence of specified significant events. In addition, while U.S. domestic issuers that are not large accelerated filers or accelerated filers are required to file their annual reports on Form 10-K within 90 days after the end of each fiscal year, foreign private issuers are not required to file their annual report on Form 20-F until 120 days after the end of each fiscal year. Foreign private issuers are also exempt from the Regulation Fair Disclosure, aimed at preventing issuers from making selective disclosures of material information.

 

We have never paid cash dividends on our capital stock and we do not anticipate paying any dividends in the foreseeable future. Consequently, any gains from an investment in our common shares will likely depend on whether the price of our Common shares increases, which may not occur

 

We have not paid cash dividends on any capital stock to date and we currently intend to retain our future earnings, if any, to fund the development and growth of our business. Consequently, in the foreseeable future, you will likely only experience a gain from your investment in our Common shares if the price of our Common shares increases beyond the price in which you originally acquired the Common shares.

 

In the event a market develops for our common shares or Warrants, the market price of our common shares or Warrants may be volatile

 

In the event a market develops for our common shares or Warrants, the market price of our common shares or Warrants may be highly volatile. Some of the factors that may materially affect the market price of our common shares or Warrants are beyond our control, such as changes in financial estimates by industry and securities analysts, conditions or trends in the industry in which we operate or sales of our common shares or Warrants. These factors may materially adversely affect the market price of our common shares or Warrants, regardless of our performance. In addition, the public stock markets have experienced extreme price and trading volume volatility. This volatility has significantly affected the market prices of securities of many companies for reasons frequently unrelated to the operating performance of the specific companies. These broad market fluctuations may adversely affect the market price of our Common shares.

 

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Our executive officers, directors and principal shareholders will maintain the ability to exert significant control over matters submitted to our shareholders for approval

 

Assuming the sale by us of 3,268,765 Common Units in this offering (or 3,759,080 Common Units if the underwriters exercise their option to purchase additional shares in full), our executive officers, directors and principal shareholders who owned more than 5% of our outstanding common shares before this offering will, in the aggregate, beneficially own shares representing approximately 5.98% (or 5.33% if the underwriters exercise their option to purchase additional securities in full) of our share capital following the completion of this offering. As a result, if these shareholders were to act together, they would be able to control all matters submitted to our shareholders for approval, as well as our management and affairs. For example, these persons, if they act together, would control the election of directors and approval of any merger, consolidation or sale of all or substantially all of our assets. This concentration of voting power could delay or prevent an acquisition of our company on terms that other shareholders may desire or result in management of our company that our public shareholders disagree with.

 

If you purchase our Common Units or Pre-funded Units in this offering, you will incur immediate and substantial dilution in the book value of your shares

 

The public offering price of our Common Units and Pre-funded Units will be substantially higher than the net tangible book value per share of our common shares. Therefore, if you purchase securities in this offering, you will pay a price per share that substantially exceeds our net tangible book value per share after this offering. To the extent outstanding options and warrants are exercised, you will incur further dilution. Based on the assumed public offering price of US$4.25 per Common Unit (being the low end in the estimated offering price range for the Common Units of between US$4.25 and US$4.50), assuming no sale of Pre-funded Units and no exercise of the Warrants being offered in this offering, you will experience immediate dilution of US$2.11 per share, representing the difference between our as adjusted net tangible book value per share after giving effect to this offering at the assumed offering price per Common Unit. In addition, all purchasers of Common Units, assuming no sale of Pre-funded Units and no exercise of the Warrants being offered in this offering, will own only approximately 81% of our common shares outstanding after this offering.

 

Our management will have broad discretion in the use of the net proceeds from this offering and may allocate the net proceeds from this offering in ways that you and other shareholders may not approve

 

Our management will have broad discretion in the use of the net proceeds, including for any of the purposes described in the section titled “Use of Proceeds,” and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use.

 

If we are or become classified as a passive foreign investment company, our U.S. shareholders may suffer adverse tax consequences as a result

 

Generally, for any taxable year, if at least 75% of our gross income is passive income, or at least 50% of the value of our assets is attributable to assets that produce passive income or are held for the production of passive income, including cash, we would be characterized as a passive foreign investment company, or PFIC, for U.S. federal income tax purposes. For purposes of these tests, passive income includes dividends, interest gains from commodities and securities transactions, the excess of gains over losses from the disposition of assets which produce passive income (including amounts derived by reason of the temporary investment of funds raised in offerings of our shares) and rents and royalties other than rents and royalties which are received from unrelated parties in connection with the active conduct of a trade or business. If we are characterized as a PFIC, our U.S. shareholders may suffer adverse tax consequences, including having gains realized on the sale of our common shares treated as ordinary income, rather than capital gain, the loss of the preferential rate applicable to dividends received on our common shares by individuals who are U.S. holders, and having interest charges apply to distributions by us and gains from the sales of our shares.

 

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Our status as a PFIC will depend on the nature and composition of our income and the nature, composition and value of our assets. Asset value is based on which the fair market value of each asset, including goodwill and going concern value (which may be determined by reference to the market value of our common shares, which may be volatile). Our status will also depend, in part, on when and how we utilize the cash proceeds from this offering in our business. Based upon the value of our assets, including any goodwill, and the nature and composition of our income and assets, we believe that we will be classified as a PFIC for the taxable year ending July 31, 2020 and possibly for succeeding years. However, even if we are classified as a PFIC for the year ending July 31, 2020, under an exception to the PFIC classification rules, we may be able to avoid such classification altogether if we can meet certain conditions set forth in the exception. (See the discussion of PFIC status under “Taxation, U.S. Federal Income Taxation”, below. Because the determination of whether we are a PFIC for any taxable year is a factual determination made annually after the end of each taxable year, there can be no assurance as to our status as a PFIC in any taxable year.

 

The tax consequences that would apply if we are classified as a PFIC would also be different from those described above if a U.S. shareholder were able to make a valid qualified electing fund, or QEF, election. If we are classified as a PFIC then we expect to provide U.S. shareholders with the information necessary for a U.S. shareholder to make a QEF election but there is no assurance that we will do so. See the discussion of PFIC status under “Taxation, U.S. Federal Income Taxation”, below.

 

If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they adversely change their recommendations or publish negative reports regarding our business or our shares, our share price and trading volume could decline

 

The trading market for our securities will be influenced by the research and reports that industry or securities analysts may publish about us, our business, our market or our competitors. We do not have any control over these analysts and we cannot provide any assurance that analysts will cover us or provide favorable coverage. If any of the analysts who may cover us adversely change their recommendation regarding our shares, or provide more favorable relative recommendations about our competitors, the market value of our securities would likely decline. If any analyst who may cover us were to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause the price of our common shares and Warrants and our trading volume to decline.

 

Certain Canadian legislation contain provisions that may have the effect of delaying or preventing a change in control

 

Canadian legislation could discourage potential acquisition proposals, delay or prevent a change in control and limit the price that certain investors may be willing to pay for our subordinate voting shares. For instance, a non-Canadian must file an application for review with the Minister responsible for the Investment Canada Act and obtain approval of the Minister prior to acquiring control of a “Canadian business” within the meaning of the Investment Canada Act, where prescribed financial thresholds are exceeded. Furthermore, limitations on the ability to acquire and hold our subordinate voting shares and multiple voting shares may be imposed by the Competition Act (Canada). This legislation permits the Commissioner of Competition, or Commissioner, to review any acquisition or establishment, directly or indirectly, including through the acquisition of shares, of control over or of a significant interest in us. Otherwise, there are no limitations either under the laws of Canada or British Columbia, or in our articles on the rights of non-Canadians to hold or vote our subordinate voting shares and multiple voting shares. Any of these provisions may discourage a potential acquirer from proposing or completing a transaction that may have otherwise presented a premium to our shareholders. See “Description of Securities—Certain Important Provisions of Our Articles and the BCBCA.”

 

Because we are a corporation incorporated in British Columbia and some of our directors and officers are resident in Canada, it may be difficult for investors in the United States to enforce civil liabilities against us based solely upon the federal securities laws of the United States. Similarly, it may be difficult for Canadian investors to enforce civil liabilities against our directors and officers residing outside of Canada

 

We are a corporation incorporated under the laws of British Columbia with our principal place of business in West Vancouver. Some of our directors and officers and the auditors or other experts named herein are residents of Canada and all or a substantial portion of our assets and those of such persons are located outside the United States. Consequently, it may be difficult for U.S. investors to effect service of process within the United States upon us or our directors or officers or such auditors who are not residents of the United States, or to realize in the United States upon judgments of courts of the United States predicated upon civil liabilities under the Securities Act. Investors should not assume that Canadian courts: (1) would enforce judgments of U.S. courts obtained in actions against us or such persons predicated upon the civil liability provisions of the U.S. federal securities laws or the securities or blue sky laws of any state within the United States or (2) would enforce, in original actions, liabilities against us or such persons predicated upon the U.S. federal securities laws or any such state securities or blue sky laws.

 

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Similarly, some of our directors and officers are residents of countries other than Canada and all or a substantial portion of the assets of such persons are located outside Canada. As a result, it may be difficult for Canadian investors to initiate a lawsuit within Canada against these non-Canadian residents. In addition, it may not be possible for Canadian investors to collect from these non-Canadian residents judgments obtained in courts in Canada predicated on the civil liability provisions of securities legislation of certain of the provinces and territories of Canada. It may also be difficult for Canadian investors to succeed in a lawsuit in the United States, based solely on violations of Canadian securities laws.

 

A conflict of interest may arise between us and one of our named experts who is also a selling shareholder.

 

The law firm of Sichenzia Ross Ference LLP is our legal counsel. We have issued a total of 50,000 shares to Sichenzia Ross Ference LLP as consideration for legal services rendered to us, of which all 50,000 shares are being registered for resale in the Selling Shareholder Prospectus. A conflict of interest may arise between us and the selling shareholder as while this shareholder has expressed an intent not to sell shares prior to the closing of or concurrently with the primary offering, if it did do so, such sales might affect the price, demand, and liquidity of our common shares.

 

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

 

Some discussions in this prospectus may contain forward-looking statements that involve risks and uncertainties. These statements relate to future events or future financial performance. A number of important factors could cause our actual results to differ materially from those expressed in or implied by any forward-looking statements made by us in this prospectus. Forward-looking statements are often identified by words like: “believe,” “expect,” “estimate,” “anticipate,” “intend,” “project,” “may,” “will,” “should,” “plans,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section titled “Risk Factors” beginning on page 19, that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. In addition, you are directed to factors discussed in the “Description of Business” section beginning on page 50, the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section beginning on page 42, as well as those discussed elsewhere in this prospectus.

 

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, or achievements. Except as required by applicable law, including the securities laws of the United States and Canada, we do not intend to update any of the forward-looking statements to conform these statements to actual results.

 

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USE OF PROCEEDS

 

We estimate that the net proceeds from this offering will be approximately US$12,000,000, assuming we sell only Common Units in this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, based on the assumed public offering price of US$4.25 per Common Unit (being the low end in the estimated offering price range for the Common Units of between US$4.25 and US$4.50). If the underwriters exercise their overallotment option in full, we estimate that the net proceeds to us from this offering will be approximately US$14,000,000, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

 

Assuming net proceeds of US$12,000,000 we intend to use US$6,100,000 of the net proceeds from this offering for clinical trials of Bria-IMT™, which should allow us to advance Bria-IMT™ through phase IIa to an “End of Phase II” meeting with the FDA, permitting us to determine the design of a registration study and negotiate with the FDA to obtain a “Special Protocol Assessment” (SPA) of the registration study. Under the SPA, the FDA would agree with the design and endpoints of a registration study and if these endpoints are met, would agree to grant marketing approval of the drug. In addition, US$1,100,000 will be devoted to initial clinical trials of Bria-OTS™, which should progress Bria-OTS™ through the end of Phase I evaluation and permit the start of Phase IIa evaluation. There will be $433,400 devoted to the Cooperative Research and Development Agreement with the National Cancer Institute to develop and test BriaCell Therapeutic Corp.’s proprietary Bria-OTS cellular immunotherapy as a treatment for cancer to improve and broaden applicability of this therapeutic strategy. The remainder will be for Discovery Research and manufacturing (CMC) costs (approximately US$2,658,600) and working capital and general corporate purposes (approximately US$1,708,000).

 

We would receive additional gross proceeds of $[*] if all of the Warrants included in the units are exercised, assuming no exercise of the underwriters’ over-allotment option. We intend to use any such proceeds for working capital and general corporate purposes. General corporate purposes may include capital expenditures.

 

We may also use a portion of the net proceeds from this offering to acquire or invest in complementary products, technologies or businesses, although we have no present agreements or commitments to do so.

 

Although we currently anticipate that we will use the net proceeds from this offering as described above, there may be circumstances where a reallocation of funds is necessary. Due to the uncertainties inherent in the clinical development and regulatory approval process, it is difficult to estimate with certainty the exact amounts of the net proceeds from this offering that may be used for any of the above purposes on a stand-alone basis. Amounts and timing of our actual expenditures will depend upon a number of factors, including our sales, marketing and commercialization efforts, regulatory approval and demand for our product candidates, operating costs and other factors described under “Risk Factors” in this prospectus. Accordingly, our management will have flexibility in applying the net proceeds from this offering. An investor will not have the opportunity to evaluate the economic, financial or other information on which we base our decisions on how to use the proceeds.

 

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DILUTION

 

If you invest in our Common Units in this offering, your interest will be immediately diluted to the extent of the difference between the public offering price per Common Unit in this offering and the as further adjusted net tangible book value per common share after this offering. Dilution results from the fact that the public offering price per Common Unit is substantially in excess of the net tangible book value per common share. As of July 31, 2020, we had a historical net tangible book value of (negative $4.55 million, or negative $6.30 per common share). Our net tangible book value per share represents total tangible assets less total liabilities, divided by the number of common shares outstanding on July 31, 2020.

 

After giving effect to the sale of Common Units in this offering at an assumed public offering price of US$4.25 per Common Unit (being the low end in the estimated offering price range for the Common Units of between US$4.25 and US$4.50), after deducting the estimated underwriting discounts and commissions and estimated offering expenses, assuming no sale of Pre-funded Units in the offering and assuming that the underwriters do not exercise in full their option to purchase additional Common Units, our as adjusted net tangible book value at July 31, 2020 would have been $2.97 per share. This represents an immediate increase in as adjusted net tangible book value of $9.27 per share to existing shareholders and immediate dilution of $2.73 per share to new investors.

 

The following table illustrates this dilution per common share:

 

Assumed public offering price per Common Unit (US$)(1)           US$ 4.25  
                 
Public offering price per Common Unit(1)           $ 5.70  
Historical net tangible book value per common share as of July 31, 2020   $ (6.30        
Increase in as adjusted net tangible book value per common share attributable to the net proceeds from new investors   $ 9.27          
As adjusted net tangible book value per common share after this offering           $ 2.87  
Dilution per common share to new investors participating in this offering           $ 2.83  

 

(1) U.S Dollar amounts converted into Canadian dollars ($) as set out in “Currency and Exchange Rates”.

 

If the underwriters exercise in full their option to purchase additional Common Units, the as adjusted net tangible book value will increase to $3.12 per common share, representing an immediate increase in as adjusted net tangible book value to existing shareholders of $9.42 per common share and an immediate dilution of $2.57 per common share to new investors participating in this offering.

 

We may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our equity holders.

 

The above discussion and tables are based on 721,962 common shares outstanding as July 31, 2020 and excludes the following: 

 

  178,528 common shares issuable upon the exercise of outstanding warrants, at a weighted average exercise price of $44.19;
     
  13,790 common shares issuable upon the exercise of outstanding compensation warrants, at a weighted average exercise price of $45;
     
  912 common shares issuable upon the granting of 912 warrants arising from the exercise of 912 compensation warrants at a weighted average exercise price of $90.00;
     
  19,969 common shares issuable upon the exercise of outstanding options, at a weighted average exercise price of $49.00; and
     
  an estimated 3,268,765 common shares issuable upon exercise of the Warrants included in the Common Units (or 3,759,080 common shares if the underwriters exercise their over-allotment option in full with respect to the Warrants contained in the Units) and an estimated 187,954 common shares issuable upon exercise of the underwriter warrants.

 

DIVIDEND POLICY

 

We do not anticipate that we will declare or pay dividends in the foreseeable future on our common shares. Instead, we anticipate that all of our earnings will be used for the operation and growth of our business. Any future determination to declare cash dividends would be subject to the discretion of our Board and would depend upon various factors, including our results of operations, financial condition and liquidity requirements, restrictions that may be imposed by applicable law and our contracts and other factors deemed relevant by our Board.

 

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CAPITALIZATION

 

The following table sets forth our consolidated capitalization as of July 31, 2020:

 

  - on an actual basis, as determined in accordance with IFRS; and
     
  - on an as-adjusted basis to reflect the net proceeds from our sale of 3,268,765 Common Units in this offering at the assumed public offering price of US$4.25 per Common Unit (being the low end in the estimated offering price range for the Common Units of between US$4.25 and US$4.50), after deducting the underwriting discounts and commissions and the estimated offering expenses, assuming no sale of Pre-funded Units and assuming that underwriters do not exercise in full their option to purchase additional Common Units.

 

This table should be read in conjunction with the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Use of Proceeds” sections, as well as our audited financial statements, included elsewhere in this prospectus. The following table assumes no exercise by the underwriters of the overallotment option to purchase additional common shares in this offering.

 

    As of July 31, 2020
    Actual   Pro Forma
Adjustments
  Pro Forma
As Adjusted(2)
             
Cash   $ 26,104       15,951,059     $ 15,977,163  
                         
Stockholders’ equity:                        
Common shares, no par value; unlimited number of shares authorized, 721,962 shares issued and outstanding, actual; unlimited number of shares authorized, 4,040,727 shares issued and outstanding, pro forma;     15,065,961       10,088,565       25,154,526  
Share based payment reserve     739,193               739,193  
Warrant reserve     2,271,910       6,374,159       8,646,069  
Accumulated other comprehensive loss     (170,374 )             (170,374 )
Retained deficit     (22,326,312 )     (511,665 )     (22,837,977 )
                         
Total stockholders’ equity (deficit)     (4,419,622 )             11,531,437  
                         
Total capitalization   $ (4,419,622 )           $ 11,531,437  

 

(1) Reflects assumed raise of US$13,892,000 and an assumed stock price of US$3.91 per share net of transaction related fees and converted into Canadian dollars as set out in “Currency and Exchange Rates”.
   
(2) The pro forma as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of our initial public offering determined at pricing.

 

Holders

 

We had 49 holders of record for our common shares as of December 10, 2020.

 

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ENFORCEMENT OF CIVIL LIABILITIES

 

We are incorporated under the laws of British Columbia. Some of our directors and officers, and some of the experts named in this prospectus, are residents of Canada or otherwise reside outside of the United States, and all or a substantial portion of their assets, and all or a substantial portion of our assets, are located outside of the United States. We have appointed an agent for service of process in the United States, but it may be difficult for shareholders who reside in the United States to effect service within the United States upon those directors, officers and experts who are not residents of the United States. It may also be difficult for shareholders who reside in the United States to realize in the United States upon judgments of courts of the United States predicated upon our civil liability and the civil liability of our directors, officers and experts under the United States federal securities laws. There can be no assurance that U.S. investors will be able to enforce against us, members of our Board, officers or certain experts named herein who are residents of Canada or other countries outside the United States, any judgments in civil and commercial matters, including judgments under the federal securities laws.

 

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SELECTED CONSOLIDATED FINANCIAL DATA

 

The selected financial information set forth below has been derived from our audited consolidated financial statements for the fiscal years ended July 31, 2020, 2019, 2018, 2017 and 2016. You should read the following summary financial data for the years ended July 31, 2020 and 2019 together with our historical financial statements and the notes thereto included elsewhere in this prospectus and with the information set forth in the section titled “Management’s Discussion and Analysis of Financial Conditions and Results of Operations”. The audited financial statements for the years ended July 31, 2018, 2017 and 2016 are not included in this prospectus.

 

       As of July 31, 
   2020   2019   2018   2017   2016 
Balance Sheet Data                           
Cash and cash equivalents    26,104     192,916    938,448    1,264,429    171,865 
Total Assets    641,684     546,259    2,977,140    2,039,199    1,091,587 
Total Liabilities    5,061,306     1,392,396    1,745,850    1,104,147    63,470 
Total Shareholders’ Equity (deficit)    (4,419,622 )   (846,137)   1,231,290    935,052    1,028,117 

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion and analysis should be read in conjunction with our financial statements and related notes included elsewhere in this prospectus. This discussion and other parts of this prospectus contain forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under “Risk Factors” and elsewhere in this prospectus.

 

The preparation of financial statements in conformity with these accounting principles requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent liabilities at the financial statement date and reported amounts of revenue and expenses during the reporting period. On an on-going basis, we review our estimates and assumptions. The estimates were based on historical experience and other assumptions that we believe to be reasonable under the circumstances. Actual results are likely to differ from those estimates or other forward-looking statements under different assumptions or conditions, but we do not believe such differences will materially affect our financial position or results of operations. Our actual results may differ materially as a result of many factors, including those set forth under the headings entitled “Special Note Regarding Forward-Looking Statements” and “Risk Factors”.

 

Recent Developments

 

Conversion of Certain Convertible Notes

 

During the year ended July 31, 2019, 22,488 shares were issued at $30.00 per share in respect of the partial conversion of certain Convertible Notes. Upon exercise of these Convertible Notes, Noteholders received 22,488 warrants with an exercise price of $42.00, expiring within three years. On April 23, 2019, the Company revised the exercise price of these warrants from $42 to $36, and all future warrants to be issued in respect of the conversion of the balance of the Convertible Notes.

 

Repayment of Convertible Notes

 

On September 10, 2019, the Convertible Notes were repaid in the total amount of $477,599 (US$ 362,819).

 

Issuance of a Convertible Debenture

 

On November 17, 2020, BriaCell announced the completion of a brokered private placement of an unsecured convertible debenture unit of BriaCell (the “Unit”) to a single subscriber, purchased at a price of $375,000, less an original discount of approximately 29.33%, for aggregate gross proceeds of $265,000. The Unit is comprised of (A) a 5.0% convertible unsecured debenture (the “Debenture”) with a principal amount of $375,000 (“Principal Amount”), due on the earlier of (i) November 16, 2025; (ii) BriaCell receiving at least $2,000,000, in the aggregate, in one or multiple closings, by way of private placement or public offering of any equity or voting securities, or securities convertible into or exchangeable for equity or voting securities, of the Corporation; or (iii) such earlier date as the principal amount hereof may become due, subject to extension upon mutual agreement of BriaCell and the holder of the Debenture; and (B) 69,188 common share purchase warrants of BriaCell (“Unit Warrants”).

 

The Debenture is convertible, at the option of the holder thereof, from the period beginning on May 16, 2021 until the repayment of the Debenture in full, into that number of common shares of the Company (“Common Shares”) computed on the basis of the Principal Amount divided by the conversion price of $5.42 per Common Share, subject to adjustment. Each Warrant has a five (5) year term and entitles the holder to purchase one common share (“Unit Warrant Share”) at an exercise price of $5.42 per Unit Warrant Share, subject to adjustment.

 

The Debenture will bear interest at a rate of 5.0% per annum and the Debenture may be prepaid in full or in part by BriaCell during the initial 120 day period after issuance of the Debenture without penalty. After 120 days, and only if BriaCell elects to prepay the Debenture prior to November 16, 2021, BriaCell will be required to pay a cash prepayment penalty equal to 35% of the Principal Amount (the “Prepayment Penalty”). In the event of default on the Debenture, the interest rate will increase to 12% per annum and a cash penalty payment equal to 40% of the Principal Amount will be added to the Principal Amount (the “Default Penalty”); and the Principal Amount, any accrued and unpaid interest and any other amount owing pursuant the Debenture, including any Prepayment Penalty and/or Default Penalty outstanding at that time shall be accelerated, and shall become immediately due and payable at the option of the holder.

 

As consideration for the services rendered by ThinkEquity, a division of Fordham Financial Management, Inc. (the “Unit Broker”), the Unit Broker received a cash commission of $26,500 from BriaCell and also received 4,890 non-transferable compensation warrants (the “Compensation Warrants”). Each Compensation Warrant is exercisable to acquire one Common Share at an exercise price of $5.42 at any time in whole or in part for a period of five (5) years from the date of issue.

 

Changes in warrants, compensation warrants and options

 

During year ended July 31, 2019, 3,333 shares were issued in respect of 3,333 warrants that were exercised at an exercise price of $42.00 for gross proceeds of $140,000.

 

On August 19, 2019, 28,333 warrants and 1,983 compensation warrants expired.

 

On September 9, 2019, the Company issued a total of 166 stock options to a consultant, which vested immediately and expire on September 9, 2024.

 

On November 1, 2019, 2,107 stock options expired and on December 21, 2019, 3,405 warrants expired.

 

On February 14, 2020, 833 stock options expired and on March 22, 2020, 500 stock options expired.

 

On November 4, 2020, 1,917 stock options expired.

 

As described above, on November 17, 2020, the Company issued 69,188 warrants and 4,890 broker warrants in connection with the issuance of the Debenture.

 

Private Placements

 

On February 26, 2019, BriaCell announced a non-brokered private placement financing of 16,667 common shares of the Company at a price of $30.00 per common share for gross proceeds of $500,000. Recently-appointed Director of the Company, Jamieson Bondarenko, purchased the 16,667 common shares. Upon closing of the offering, Mr. Bondarenko had a beneficial ownership of an aggregate of 76,902 common shares, representing approximately 13.7% of BriaCell’s issued and outstanding common shares.

 

On April 1, 2019, BriaCell announced that it completed a non-brokered private placement of 99,117 common shares of the Company at a price of $30.00 per common share for gross proceeds of $2,973,524 (the “Private Placement”) which includes Mr. Bondarenko’s $500,000 equity investment.

 

On September 9, 2019, the Company closed its previously-announced non-brokered private placement (the “Offering”) of common shares in the capital of the Company. Under the Offering, the Company issued a total of 40,300 common shares at a price of $21.00 per common share for gross proceeds of $846,300 (“September 2019 Private Placement”).

 

On October 15, 2019, the Company completed non brokered private placement of 27,069 common shares at a price of $21.00 per common share for gross proceeds of $568,444 (“October 2019 Private Placement”).

 

Shares issued as compensation for legal services

 

On August 18, 2020, BriaCell issued 50,000 restricted common shares to Sichenzia Ross Ference LLP as compensation for legal services.

 

Loan agreements

 

On December 3, 2019, the Company received an unsecured US$100,000 loan from ClearIt, LLC, which bears interest at 2.5% annually. The repayment of the loan was due on or before March 26, 2020, after which the interest rate on any remaining due but unpaid balance would increase to 15% annually. On October 15, 2020, the creditor deferred the increased interest start date from March 26, 2020 to November 21, 2020. Martin Schmieg, a Company director, is the General Manager and Chief Executive Officer of ClearIt, LLC. Mr. Schmeig was not a director of the Company at the time this transaction occurred.

 

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On January 27, 2020, the Company received an unsecured US$50,000 loan from ClearIt, LLC which bears interest at 2.5% annually. The repayment of the loan was due on or before March 26, 2020, after which the interest rate on any remaining due but unpaid balance would increase to 15% annually. On October 15, 2020, the creditor deferred the increased interest start date from March 26, 2020 to November 21, 2020. Mr. Schmeig was not a director of the Company at the time this transaction occurred.

 

On February 20, 2020, the Company received an unsecured US$50,000 loan from ClearIt, LLC which bears interest at 2.5% annually. The repayment of the loan was due on or before March 26, 2020, after which the interest rate on any remaining due but unpaid balance would increase to 15% annually. On October 15, 2020, the creditor deferred the increased interest start date from March 26, 2020 to November 21, 2020. Mr. Schmeig was not a director of the Company at the time this transaction occurred.

 

On April 24, 2020, the Company received a $40,000 loan from the Canada Emergency Business Account (“CEBA Loan”). The CEBA Loan bears 0% interest until December 31, 2022. If the balance is not repaid by December 31, 2022, the remaining balance will be converted to a 3-year term loan at 5% annual interest, paid monthly, effective January 1, 2023. The full balance must be repaid by no later than December 31, 2025. No principal payments are required until December 31, 2022. Principal repayments can be voluntarily made at any time without fees or penalties. $10,000 of the CEBA Loan may be forgiven provided that the outstanding balance is $40,000 as at December 31, 2020, and that $30,000 is repaid between January 1, 2021 and December 31, 2022.

 

On May 1, 2020 the Company received US$127,030 as a loan from the Paycheck Protection Program in the United States (the “Program”). The terms of the Program provide that a portion of the loan may be forgiven, to the extent that the amounts spent during the eight week period following the first disbursement of the loan are incurred as follows: (i) payroll costs, (ii) interest payments on mortgages incurred before February 15, 2020, (iii) rent payments on leases in effect before February 15, 2020, and (iv) utility payments for which service began before February 15, 2020. The unforgiven part of the loan must be repaid within two years and bears interest at 1% per annum.

 

New Board Composition

 

In February and March 2019, the Company’s Board was substantially restructured with the appointment of Jamieson Bondarenko, Dr. Rebecca Taub and Vaughn C. Embro-Pantalony to replace three resigning directors. Additionally, on August 12, 2019, Richard Berman was appointed to our Board but later resigned in October 26, 2020 citing other commitments. On November 24, 2020, Martin Schmieg rejoined the Board. After these restructuring events, the current Board consists of:

 

  Dr. William V. Williams, Director and Chief Executive Officer;
     
  Jamieson Bondarenko, Director and Chairman of the Board;
     
  Dr. Charles Wiseman, Director;
     
  Dr. Rebecca Taub, Director
     
  Vaughn C. Embro-Pantalony, Director; and
     
  Martin Schmieg, Director

 

Overview

 

Critical Accounting Policies and Estimates

 

1. Critical Estimates and Judgements

 

The preparation of these consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual outcomes could differ from these estimates. The financial statements include estimates which, by their nature, are uncertain. The impacts of such estimates are pervasive throughout the financial statements, and may require accounting adjustments based on future occurrences. Revisions to accounting estimates are recognized in the period in which the estimate is revised and also in future periods when the revision affects both current and future periods.

 

The critical judgments and significant estimates in applying accounting policies that have the most significant effect on the amounts recognized in the consolidated financial statements are:

 

  The series of loans made to the subsidiary company are considered part of the parent company’s net investment in a foreign operation as the Company does not plan to settle these balances in the foreseeable future. As a result of this assessment, the unrealized foreign exchange gains and losses on the intercompany loans are recorded through comprehensive loss. If the Company determined that settlement of these amounts was planned or likely in the foreseeable future, the resultant foreign exchange gains and losses would be recorded through profit or loss.
  The change in the fair value of the unsecured convertible loan is based on an estimate determined by the Black-Scholes Model.
  Preparation of the consolidated financial statement on going concern basis, which contemplates the realization of assets and payments of liabilities in the ordinary course of business. Should the Company be unable to continue as a going concern, it may be unable to realize the carrying value of its assets and to meet its liabilities as they become due.
  Intangible assets are tested for impairment annually or more frequently if three is an indication of impairment. The carrying value of intangibles with definite lives is reviewed each reporting period to determine whether there is any indication of impairment. If there are indications of impairment the impairment analysis is completed and if the carrying amount of an asset exceeds its recoverable amount, the asset is impaired and impairment loss is recognized.

 

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2. New Accounting Policies Adopted

 

During the year ended July 31, 2020, the following new accounting policies were adopted.

 

IFRS 16 - Leases (“IFRS 16”)

 

IFRS 16 supersedes IAS 17 Leases, IFRIC 4 Determining whether an arrangement contains a lease, SIC-15 Operating Leases - Incentives and SIC-27 Evaluating the Substance of Transactions Involving the Legal Form of a Lease. It eliminates the distinction between operating and finance leases from the perspective of the lessee. All contracts that meet the definition of a lease will be recorded in the consolidated statements of financial position with a “right of use” asset and a corresponding liability. The asset is subsequently accounted for as property, plant and equipment or investment property and the liability is unwound using the interest rate inherent in the lease. The Company has adopted IFRS 16 as of August 1, 2019, and has assessed no changes to the opening consolidated statements of financial position as a result of the adoption of this new standard.

 

On transition to IFRS 16, the Company has elected to apply the practical expedient to grandfather the assessment of which transactions are leases and apply IFRS 16 only to contracts that were previously identified as leases. Contracts that were not identified as leases under IAS 17 Leases have not been reassessed for whether a lease exists. The Company has elected to not recognize right-of-use assets and lease liabilities for leases that have a lease term of 12 months or less and for leases of low-value assets.

 

IFRIC 23 - Uncertainty over Income Tax Treatments (“IFRIC 23”)

 

The Company adopted IFRIC 23 on July 1, 2019 on a modified retrospective basis without restatement of comparative information. The interpretation requires an entity to assess whether it is probable that a tax authority will accept an uncertain tax treatment used, or proposed to be used, by an entity in its income tax filings and to exercise judgment in determining whether each tax treatment should be considered independently or whether some tax treatments should be considered together. The decision should be based on which approach provides better predictions of the resolution of the uncertainty. An entity also has to consider whether it is probable that the relevant authority will accept each tax treatment, or group of tax treatments, assuming that the taxation authority with the right to examine any amounts reported to it will examine those amounts and will have full knowledge of all relevant information when doing so. The adoption of the new standard had no impact on the consolidated financial statements as at July 31, 2020.

 

IFRS 3 - Business Combinations (“IFRS 3”)

 

In October 2018, the IASB issued an amendment to IFRS 3, effective for annual periods beginning on or after January 1, 2020 with early adoption permitted. The amendment clarifies that a business must include, at minimum, an input and a substantive process that together contribute to the ability to create outputs, and assists companies in determining whether an acquisition is a business combination or an acquisition of a group of assets by providing supplemental guidance for assessing whether an acquired process is substantive. The Company has decided to early adopt the amendments to IFRS 3 effective August 1, 2019 and shall apply the amended standard in assessing business combinations on a prospective basis. For acquisitions that are determined to be acquisitions of assets as opposed to business combinations, the Company allocates the transaction price to the individual identifiable assets acquired and liabilities assumed on the basis of their relative fair values, and no goodwill is recognized. Acquisitions that continue to meet the definition of a business combination are accounted for under the acquisition method, without any changes to the Company’s accounting policy. There was no impact on the Company’s consolidated financial statements as at July 31, 2020. 

 

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Results of Operations

 

Comparison of the year ended July 31, 2020, compared to the year ended July 31, 2019

 

Research Costs

 

Research costs are comprised primarily of (i) Salaries and wages to Company employees at our laboratory; (ii) Clinical trials and investigational drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials; (iii) Licensing of our immunotherapy; and (iv) legal fees in respect of maintaining and expanding our portfolio of patents.

 

For the year ended July 31, 2020, research costs amounted to $2,980,144 as compared to $4,917,287 for the year ended July 31, 2019. The decrease related to the slowdown in clinical trials due the effects of COVID-19.

 

General and Administrative Expenses

 

For the year ended July 31, 2020, general and administrative expenses amounted to $1,857,465 as compared to $1,244,471 for the year ended July 31, 2019. The increase is primarily due to an increase of professional fees incurred as part of our application for listing of the Company’s common shares on The Nasdaq Capital Market in the United States, offset by a decrease in shareholder communication expenses and consulting fees.

 

Share-based Compensation

 

For the year ended July 31, 2020, share based compensation of $2,071 as compared to $60,586 for the year ended July 31, 2019. The current charge relates to the fair value of the options that were issued during this period.

 

Interest Income

 

For the year ended July 31, 2020, interest income amounted to $nil as compared to $12,004 for the year ended July 31, 2019. Interest income earned during each quarter is a function of the amount of funds held in interest bearing accounts.

 

Interest expense

 

For the year ended July 31, 2020, interest expense amounted to $36,216 as compared to $31,317 for the year ended July 31, 2019. Interest expense during the current period relates to credit card interest charges, interest on short term loans and interest expense in respect of the interest bearing convertible debt from March 2018 that was repaid in September 2019.

 

Interest expense in the prior period was incurred as a result of the issuance of interest bearing convertible debt in March 2018.

 

Gain from government grants

 

For the year ended July 31, 2020, the gain for government grants was $28,604 as compared to nil for the year ended July 31, 2019. The gain from the government grants represents the benefit of receiving grants at interest rates below market rates.

 

Change in fair value of convertible debt

 

For the year ended July 31, 2020, the increase in fair value of convertible debt amounted to $79,119 as compared to a decrease of $420,585 for the year ended July 31, 2019. The movement during each period is based on the fair value at the date of repayment. In September 2019, the Company repaid the convertible debt.

 

Foreign Exchange Loss/Gain

 

For the year ended July 31, 2020, foreign exchange loss of $17,810 as compared to a gain of $31,410 for the year ended July 31, 2019. The Company is exposed to financial risk related to the fluctuation of foreign exchange rates. The Company operates in the United States and Canada, most of its monetary assets are held in Canadian dollars and most of its expenditures are made in US dollars. The Company has not hedged its exposure to currency fluctuations.

 

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Loss for the period

 

The Company reported a loss for the year ended July 31, 2020 of $4,944,221 as compared to a loss of $5,789,662 for the year ended July 31, 2019. The primary reason for decrease in the loss in 2020 is due to the decrease in research and development costs offset by an increase in general and administration costs.

 

Comprehensive loss for the year

 

The Company reported a comprehensive loss for the year ended July 31, 2020 of $4,990,300 as compared to a comprehensive loss of $5,808,443 for the year ended July 31, 2020. The primary reason for decrease in the loss in 2020 is due to the decrease in research and development costs offset by an increase in general and administration costs.

 

The difference between net loss and comprehensive loss results from the foreign currency translation adjustment that arises upon the translation of the accounting records of the Company’s US subsidiary, whose functional currency is the US dollar into Canadian dollars for financial statement presentation purposes.

 

Comparison of the year ended July 31, 2019, compared to the year ended July 31, 2018

 

Research Costs

 

Research costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory, (ii) clinical trials and investigational drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials, (iii) licensing of our immunotherapy, and (iv) legal fees in respect of maintaining and expanding our portfolio of patents.

 

For the year ended July 31, 2019, research costs amounted to $4,917,287, as compared to $3,112,579 for the year ended July 31, 2018. The increase in research costs is as a result of supporting the Company’s ongoing Phase I/IIa clinical trial and relates primarily to increased clinical trial expenses, including the development of new Bria-IMT™ cell banks. BriaCell also has contracted with a second supplier of Bria-IMT™ and there is ongoing formulation work to develop a more user-friendly formulation that does not require culturing cells and same day irradiation.

 

Work also has begun on the development of Bria-OTSTM and BriaCell has submitted five grant applications, applying for non-dilutive funding to support our research efforts, using our grant consultant, the FreeMind Group.

 

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General and Administrative Expenses

 

For the year ended July 31, 2019, general and administrative expenses amounted to $1,244,471, as compared to $1,387,713 for the year ended July 31, 2018. The decrease is primarily due to decrease of consulting fees.

 

Share based Compensation

 

For the year ended July 31, 2019, share based compensation of $60,586, as compared to $476,211 for the year ended July 31, 2018. The current charge relates to the tail end of the fair value of the options that were issued during prior periods.

 

Interest Income

 

For the year ended July 31, 2019, interest income amounted to $12,004, as compared to $15,991 for the year ended July 31, 2018. Interest income earned during each quarter is a function of the amount of funds held in interest bearing accounts.

 

Interest expense

 

For the year ended July 31, 2019, interest expense amounted to $31,317, as compared to $20,364 for the year ended July 31, 2018. Interest expense is incurred as a result of the issuance of interest bearing convertible notes in March 2018. The prior period includes the issuance costs of the convertible debt.

 

Change in fair value of convertible debt

 

For the year ended July 31, 2019, the increase in fair value of the convertible debt amounted to $420,58,5 as compared to a decrease of $407,709 for the year ended July 31, 2018.

 

Foreign Exchange Gain

 

For the year ended July 31, 2019, the foreign exchange gain of $31,410, as compared to a loss of $24,078 for the year ended July 31, 2018. The Company is exposed to financial risk related to the fluctuation of foreign exchange rates. The Company operates in the United States and Canada, most of its monetary assets are held in Canadian dollars and most of its expenditures are made in US dollars. The Company has not hedged its exposure to currency fluctuations.

 

Loss for the year

 

The Company reported a loss for the year ended July 31, 2019 of $5,789,662, as compared to a loss of $5,412,663 for the year ended July 31, 2018. The primary reason for increase in the loss during the current period is due to the increased research activities compared to the prior period.

 

Comprehensive loss for the year

 

The Company reported a comprehensive loss of $5,808,443 for the year ended July 31, 2019, as compared to a comprehensive loss of $5,446,003 for the year ended July 31, 2018. The primary reason for the increase in the loss during the current period is due to the increased research activities compared to the prior period.

 

The difference between net loss and comprehensive loss results from the foreign currency translation adjustment that arises upon the translation of the accounting records of the Company’s US subsidiary, whose functional currency is the US dollar into Canadian dollars for financial statement presentation purposes.

 

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Comparison of the year ended July 31, 2018 to the year ended July 31, 2017

 

Research Costs

 

For the year ended July 31, 2018, research costs amounted to $3,112,579 as compared to $2,125,941 for the year ended July 31, 2017. The increase in research costs is as a result of supporting the Company’s ongoing Phase I/IIa clinical trial and relates primarily to increased clinical trial expenses, including the development of new BriaVax™ (a.k.a. Bria-IMT™) cell banks. BriaCell also has contracted with a second supplier of BriaVax™ (a.k.a. Bria-IMT™) and there is ongoing formulation work to develop a more user-friendly formulation that does not require culturing cells and same day irradiation. Work also has begun on the development of second generation BriaVax™ (a.k.a. Bria-IMT™) and BriaCell has submitted five grant applications, applying for non-dilutive funding to support our research efforts, using our grant consultant, the FreeMind Group.

 

General and Administrative Expenses

 

For the year ended July 31, 2018, general and administrative expenses amounted to $1,387,713, as compared to $820,281 for the year ended July 31, 2017. The increase is primarily to an increase in consulting, professional fees and Shareholder communications incurred in 2018 as compared to 2017 and is in line with the Companies increased research activities and increase investor relations activities. In addition, we incurred certain expenses in connection with the debt financing.

 

Share-based Compensation

 

For the year ended July 31, 2018, share-based compensation amounted to $476,211, as compared to $272,014 for the year ended July 31, 2017. The increase in share-based compensation in the current period is as a result of increased number of stock options granted in the year ended July 31, 2018 as compared to the prior year.

 

Interest Income

 

For the year ended July 31, 2018, interest income amounted to $15,991, as compared to $6,428 for the year ended July 31, 2017. Interest income earned during each quarter is a function of the amount of funds held in interest bearing accounts.

 

Interest expense

 

For the year ended July 31, 2018, interest expense amounted to $20,364, as compared to $nil for the year ended July 31, 2017. Interest expense was incurred from the convertible notes.

 

Change in fair value of convertible debt

 

For the year ended July 31, 2018, change in fair value of convertible debt amounted to $407,709, as compared to $nil for the year ended July 31, 2017.

 

Foreign Exchange Gain

 

For the year ended July 31, 2018, the foreign exchange loss amounted to $24,078, as compared to a loss of $8,913 for the year ended July 31, 2017. The Company is exposed to financial risk related to the fluctuation of foreign exchange rates. The Company operates in the United States and Canada, most of its monetary assets are held in Canadian dollars and most of its expenditures are made in US dollars. The Company has not hedged its exposure to currency fluctuations.

 

Loss for the year

 

The Company reported a loss of $5,412,663 for the year ended July 31, 2018, as compared to a loss of $3,220,721 for the year ended July 31, 2017. The primary reason for increase in the loss in 2018 is due to the increase in research activities, general and administrative expenses and share-based compensation.

 

Comprehensive loss for the year

 

The Company reported a comprehensive loss of $5,446,003 for the year ended July 31, 2018, as compared to a comprehensive loss of $3,178,893 for the year ended July 31, 2017. The primary reason for increase in the loss in 2018 is due to the increase in research activities, General and Administrative Expenses and Share-based Compensation.

 

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The difference between net loss and comprehensive loss results from Foreign currency translation adjustment that arises upon the translation of the accounting records of BTC who’s functional currency is the US dollar into Canadian dollars for financial statement presentation purposes.

 

Going Concern Uncertainty

 

The financial statements have been prepared on a going concern basis which assumes that the Company will be able to realize its assets and discharge its liabilities in the normal course of business for the foreseeable future. The continuing operations of the Company are dependent upon its ability to continue to raise adequate financing and to commence profitable operations in the future.

 

As at July 31, 2020, the Company has total assets of $641,684 (July 31, 2019 - $546,259) and a negative working capital balance of $4,548,526 (July 31, 2018 positive - $1,185,354).

 

It is management’s opinion that the Company will require additional funding, either through debt or equity issuances, in order to maintain its research and developmental activities. To this end, the company is currently raising funds to continue to funds its operation. These uncertainties may cast significant doubt on the Company’s ability to continue as a going concern.

 

Liquidity and Capital Resources

 

Changes in capital resources during the year ended July 31, 2020 and the year ended July 31, 2019 are described below.

 

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As of July 31, 2020 and July 31, 2019, the Company had cash of $26,104 and $196,916, respectably and negative working capital of $4,548,526 and $1,185,354, respectively. The Company has incurred significant operating losses since inception and continues to generate losses from operations and as of July 31, 2020 and July 31, 2019, the Company has an accumulated deficit of $22.3 million and $18.1 million. These matters raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date such financial statements are issued. The audited financial statements for the year ended July 31, 2020 do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

 

Historically, the Company has financed its operation through private and public placement of equity securities, as well as debt financing. The Company’s ability to fund its longer-term cash requirements is subject to multiple risks, many of which are beyond its control. The Company intends to raise additional capital, either through debt or equity financings in order to achieve its business plan objectives. Management believes that it can be successful in obtaining additional capital; however, no assurance can be provided that the Company will be able to do so. There is no assurance that any funds raised will be sufficient to enable the Company to attain profitable operations or continue as a going concern. To the extent that the Company is unsuccessful, the Company may need to curtail or cease its operations and implement a plan to extend payables or reduce overhead until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan will be successful

 

Year ended July 31, 2020

 

During the year ended July 31, 2020, the Company’s overall position of cash and cash equivalents decreased by $166,812 from the year ended July 31, 2019 (including effects of foreign exchange). This decrease in cash can be attributed to the following:

 

The Company’s net cash used in operating activities during the year ended July 31, 2020 was $1,551,162 as compared to $5,094,895 for the year ended July 31, 2019. This decrease is contributed mostly to an increase in accounts payable and accrued liabilities.

 

Cash provided from investing activities during the year ended July 31, 2020 was $nil as compared to cash provided from investment activities of $1,341,043 for the year ended July 31, 2019. The cash provided in 2019 was due to the release of short-term investments.

 

Cash provided by financing activities for the year ended July 31, 2020 was $1,442,344 as compared to $2,995,784 for the year ended July 31, 2019. Cash provided in 2020 resulted from two private placements, short term loans and a government grant, offset by the repayment of the unsecured convertible loan.

 

Year ended July 31, 2019

 

During the year ended July 31, 2019, the Company’s overall position of cash and cash equivalents decreased by $758,068, as compared to a decrease of $258,314 for the year ended July 31, 2018. This decrease in cash can be attributed to the following:

 

The Company’s net cash used in operating activities during the year ended July 31, 2019 was $5,094,895, as compared to $4,958,593 for the year ended July 31, 2018. This increase in 2019 is primarily due to the increase in research costs.

 

Cash provided from investing activities during the year ended July 31, 2019 was $1,341,043, as compared to cash used to investment activities of $591,043 for the year ended July 31, 2018. The cash provided in 2019 was due to the release of short-term investments compared to the investment of cash in short-term investments in 2018.

 

Cash provided by financing activities for the year ended July 31, 2019 was $2,995,784, as compared to $5,291,322 for the year ended July 31, 2018. Cash provided in 2019 resulted from a private placement and exercise of warrants and the cash provided in 2018 resulted from private placements and the issuance of Convertible Notes.

 

Off-balance Sheet Arrangements

 

None.

 

Tabular Disclosure of Contractual Obligations

 

The following table summarizes our contractual obligations as of July 31, 2020 and the effect those commitments are expected to have on our liquidity and cash flow.

 

       Payments due by periods 
   Total   Less than 1 year   1-3 years   3-5 years   More than 5 years 
Short term loans   $ 306,878     $ 306,878     $ -     $ -     $ -  
Government grants     210,271       -       210,271       -       -  
Total   $ 517,149     $ 306,878     $ 210,271     $ -     $ -  

 

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DESCRIPTION OF BUSINESS

 

Overview of the Company

 

BriaCell is an immuno-oncology biotechnology company with a strong focus on cancer immunotherapy. Immunotherapies have come to the forefront in the fight against cancer. They harness the body’s own immune system to recognize and destroy cancer cells. BriaCell owns the US patent to SV-BR-1-GM (Bria-IMT™), a whole-cell targeted immunotherapy for cancer (U.S. Patent No. 7,674,456), as well as patents related to PKCδ inhibitors (U.S. Patent Nos. 9,364,460 and 9,572,793). The Company is currently advancing its targeted immunotherapy program by prioritizing a Phase I/IIa clinical trial with Bria-IMT™ in combination with an immune checkpoint inhibitor and a companion diagnostic test, BriaDx™, to identify patients most likely to benefit from Bria-IMT™. The Bria-IMT™ regimen was evaluated in 4 patients in a prior study in 2004 – 2006 by Dr. Charles Wiseman, the scientific founder and member of the Board. Encouraging results were obtained, especially in a patient who matched Bria-IMT™ at the HLA-DRB3 allele and had a grade II tumor. In 2017-2018 BriaCell evaluated 23 patients with advanced breast cancer with the Bria-IMT™ regimen and obtained confirmation of the ability of the Bria-IMT™ regimen to induce regression of metastatic breast cancer in patients who match Bria-IMT™ at least at one HLA allele especially if they had grade I or grade II tumors. A combination study with the immune checkpoint inhibitor Keytruda® was initiated and the first patient dosing in the “combination therapy” clinical trial occurred in September 2018. BriaCell purchased the Keytruda for this study as BriaCell does not have an agreement with Merck for the supply of Keytruda. Eleven patients had been dosed in the combination therapy trial with Bria-IMT™ and the immune checkpoint inhibitor Keytruda and subsequently dosing with this combination was discontinued. The study was modified under an amended protocol which evaluates the combination of the Bria-IMT™ regimen with Incyte Corporation experimental drugs INCMGA00012 (anti-PD-1 antibody similar to pembrolizumab) and epacadostat (an inhibitor of the immune checkpoint enzyme indoleamine dioxygenase (IDO)). The study is ongoing.

 

The Company was incorporated under the Business Corporations Act (British Columbia) (“BCBCA”) on July 26, 2006 as Ansell Capital Corp. and is listed on the TSX Venture Exchange (“TSXV”). The Company is developing a new therapy for advanced breast cancer. The address for the Company’s headquarters is Suite 300 – 235 15th Street, West Vancouver, British Columbia, V7T 2X1. The Company’s corporate offices in the United States are located at 820 Heinz Avenue, Berkley, California 94710. The Company’s two wholly owned subsidiaries BriaCell Therapeutics Corp., a Delaware corporation (“BTC”) and Sapientia Pharmaceuticals Inc., a Delaware corporation (“Sapientia”), were formed on April 3, 2014 and September 20, 2012, respectively. The Company’s registered agent in the United States is Paracorp Incorporated located at 2804 Gateway Oaks Drive #100, Sacramento, CA 95833.

 

On July 24, 2017, the Company entered into a definitive share exchange agreement (the “Share Exchange Agreement”) between BTC, Sapientia and all the shareholders of Sapientia. Sapientia is a biotechnology company based in Havertown, PA, that is developing novel targeted therapeutics for multiple indications including several cancers and fibrotic diseases. Pursuant to the terms of the Share Exchange Agreement, BTC acquired from the Sapientia shareholders all of the issued and outstanding shares in the capital of Sapientia. As consideration, the Sapientia shareholders, received an aggregate of 8,333 common shares in the capital of BriaCell on a pro-rata basis, which were issued on September 5, 2017. As part of the share exchange, BriaCell acquired all rights, including composition of matter patents, and preclinical study data to a novel therapeutic technology platform, known as protein kinase C delta (PKCδ) inhibitors, which represents a unique, highly-targeted approach to treat cancer and to boost the immune system.

 

Market

 

It is estimated that in 2019, approximately 268,600 women will be diagnosed with breast cancer in the United States. According to the National Breast Cancer Foundation, on every two minutes an American woman is diagnosed with breast cancer and more than 40,500 die each year. Although about 100 times less common than in women, breast cancer also affects men. It is estimated that the lifetime risk of men getting breast cancer is about 1 in 1,000, and the ACS estimates that approximately 2,670 new cases of invasive male breast cancer will be diagnosed and approximately 500 men will die from breast cancer in 2019.

 

According to the May 2019 “Global Oncology Trends 2019” report by the IQVIA Institute, the global market for cancer drugs (including immunotherapy drugs) is expected to reach nearly $240 billion by the end of 2023, growing at a compound annual growth rate, or CAGR of 9-12% between 2019 and 2023.

 

About 12.8% percent of women will be diagnosed with breast cancer at some point during their lifetime. As of January 2019, there are over 3 million U.S. women who have been diagnosed with breast cancer. Approximately 80% of cases present as invasive breast cancer. 6-10% of new breast cancer diagnoses are Stage IV (metastatic or MBC, cancer which has already spread to other organs). 20-30% of all women diagnosed with breast cancer will develop MBC. Breast cancer can be subdivided based on receptor status – the hormone receptors for estrogen (ER) and progesterone (PR), collectively referred to as hormone receptors (HR), and the Her2/neu growth factor receptor (HER2). In one large study of breast cancer, 72.7% were found to be HR+/HER2−, 12.2% were triple-negative (HR−/HER2−), 10.3% were HR+/HER2+, and 4.6% were HR−/HER2+.1

 

1 Howlader, N.; Altekruse, S. F.; Li, C. I.; Chen, V. W.; Clarke, C. A.; Ries, L. A.; Cronin, K. A., US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst 2014, 106 (5).

 

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It is estimated that over 150,000 women in the US are living with metastatic breast cancer2. For those with metastatic disease at diagnosis, their 5-year survival is 27%. 3 For patients who develop MBC after initially having localized disease, if they had a good response to treatment (disease-free interval of >24 months), their survival is similar to that of patients with MBC at initial diagnosis, but if their disease-free interval is <24 months, their prognosis is worse.4 We currently propose that Bria-IMT’s indication will be for the treatment of patients with metastatic breast cancer (MBC) who have failed at least two lines of therapy. Similarly, another study showed that the median overall survival among patients with de novo stage IV MBC was 39.2 months while for patients with and relapsed disease it was 27.2 months.5 Median progression free survival after first-line therapy is only 9 months and the survival benefit decreases with subsequent lines of therapy.6 A recent study showed that of 386 patients with MBC, 374 (97%) received first-line therapy, 254 (66%) received second-line therapy, 175 (45%) received third-line therapy, and 105 (27%) received therapy beyond third-line.7

 

Figure: Overview of current drugs for breast cancer, demonstrating the pattern of novel therapeutic introductions and significant market uptake. These precedents demonstrate a strong market pull for Bria-IMT™.

 

Drug  Technology  Company  Indication  2018 Sales US (Mil US$)   2018 Sales Ex-US (Mil US$)   2018 Sales WW (Mil US$) 
HERCEPTIN® (trastuzumab)  Monoclonal antibody  Roche  HER2+BC & HER2+ metastatic gastric cancer   2,955    4,140    7,096 
IBRANCE® (palbociclib) in combination with fluvestrant or aromatase inhibitor  CDK 4/6 inhibitor  Pfizer  HR+/HER2- MBC   2,922    1,196    4,118 
PERJETA® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy  HER2/neu receptor antagonist  Roche  HER2+ early BC that has a high likelihood of recurrence   1,347    1,499    2,846 
FASLODEX® (fulvestrant)  Estrogen receptor antagonist  AstraZeneca  HR+/HER2- MBC   537    491    1,028 
KADCYLA® (ado-trastuzumab emtansine)  HER2 targeted antibody & microtubule inhibitor conjugate  Roche  HER2+BC   365    630    995 
LYNPARZA® (olaparib)  Poly (ADP-ribose) polymerase (PARP) inhibitor  AstraZeneca  BC & Ovarian cancer   345    302    647 
Verzenio® (abemaciclib) monotherapy or in combination with fulvestrant or aromatase inhibitor   CDK 4/6 inhibitor  Eli Lilly  HR+/HER2- MBC   255    -    255 
KISQALI® (ribociclib) in combination with fluvestrant or aromatase inhibitor  CDK 4/6 inhibitor  Novartis  HR+/HER2- MBC   235    -    235 

 

 

2 Mariotto AB, Etzioni R, Hurlbert M, Penberthy L, Mayer M. Estimation of the Number of Women Living with Metastatic Breast Cancer in the United States. Cancer Epidemiol Biomarkers Prev. 2017 Jun;26(6):809-815.

3 Breast Cancer Facts & Figures 2017-2018. Atlanta: American Cancer Society, Inc. 2017.

4 Lobbezoo, D. J. A. et al. Prognosis of metastatic breast cancer subtypes: the hormone receptor/HER2-positive subtype is associated with the most favorable outcome. Breast Cancer Res. Treat. 141, 507–514 (2013).

5 Dawood S, Broglio K, Ensor J, Hortobagyi GN, Giordano SH. Survival differences among women with de novo stage IV and relapsed breast cancer. Ann Oncol. 2010 Nov; 21(11):2169–74.

6 Bonotto M, Gerratana L, Iacono D, Minisini AM, Rihawi K, Fasola G, Puglisi F. Treatment of Metastatic Breast Cancer in a Real-World Scenario: Is Progression-Free Survival With First Line Predictive of Benefit From Second and Later Lines? Oncologist.

7 Kotsakis A, Ardavanis A, Koumakis G, Samantas E, Psyrri A, Papadimitriou C. Epidemiological characteristics, clinical outcomes and management patterns of metastatic breast cancer patients in routine clinical care settings of Greece: Results from the EMERGE multicenter retrospective chart review study. BMC Cancer. 2019 Jan 18;19(1):88.

 

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The best response to Bria-IMT™ to date is in patients who matched Bria-IMT™ at 1 or more HLA alleles, with higher response rates for patients with 2+ HLA allele matches. If one HLA allele match is found to be sufficient, we will be able to treat ~50-60% of the patient population, while patients with 2+ HLA matches constitutes ~15-35% of cases.8 We also saw higher clinical benefit rates for patients with grade I/II tumors. Tumor differentiation in breast cancer cell lines is often described by their classification as Luminal, Basal A and Basal B subtypes, with Luminal representing well differentiated and Basal B poorly differentiated tumors, and Basal A an intermediate stage (“moderately” differentiated) (Neve RM, Chin K, Fridlyand J, et al. A collection of breast cancer cell lines for the study of functionally distinct cancer subtypes. Cancer Cell. 2006;10(6):515-527. doi:10.1016/j.ccr.2006.10.008). Yao and colleagues in 2005 identified a 9-gene signature (AURKB, CENPI, DEPDC1, DEPDC1B, FAM83D, FGD3, NCAPH, TNFRSF18, FCGR1A) discriminating poorly (grade 3) from moderately (grade 2) differentiated tumors. (Yao F, Zhang C, Du W, Liu C, Xu Y. Identification of gene-expression signatures and protein markers for breast cancer grading and staging. PLoS One. 2015;10(9). doi:10.1371/journal.pone.0138213) To understand the place of SV-BR-1-GM in this model, we compared its RNA expression profile with those of three other cell lines representing Luminal (MCF-7), Basal A (MDA-MB-468) and Basal B (MDA-MB-231), using a 10-gene signature (AURKB, CENPI, DEPDC1, DEPDC1B, FAM83D, FGD3, NCAPH, DLGAP, KIF2C, VAV3) derived from those by Yao and colleagues. The results, shown in Figure: Bria-IMTTM Clinical Experience in Grade I/II Tumors below, demonstrate that Bria-IMT™ most closely clusters with MDA-MB-468 and as such is considered a “moderately differentiated” cell line.

 

 

Based on a recent publication of patients with relapsed breast cancer, we estimate that this will account for ~40% of relapsed metastatic breast cancer cases (33% grade II and 7% grade I) (Sundquist M, Brudin L, Tejler G. Improved survival in metastatic breast cancer 1985-2016. Breast. 2017 Feb;31:46-50. doi: 10.1016/j.breast.2016.10.005. Epub 2016 Nov 2). In patients with relapsed disease, the overall survival following relapse appears similar for those with grade II and grade III tumors3. The market for breast cancer drugs is a multibillion-dollar market with new drugs being approved on an ongoing basis, indicating the shortage of safe and effective treatments for this deadly disease. The Figure summarizes current drugs on the market utilized in combination therapy along with their reported market sales, which further supports market potential for Bria-IMTTM to be used for combination therapy for breast cancer patients.

 

We propose the following calculation in order to show the rationale behind the number of patients that we anticipate can be currently treated by SV-BR-1-GM:

 

  There are ~150,000 women with metastatic breast cancer in the US9
  45% will receive third line therapy10 = 68,000 patients available
  68,000 x ~50% (matched for 1 HLA allele group)11 = ~34,000 patients available for treatment12
  40% have grade I/II tumors3 = ~13,600 patients available for treatment

 

These assumptions above are limited to third or later lines of therapy. There is also potential to move into second-line and first-line treatment, which would markedly expand the population to be treated.

 

Treatment with a combination therapy comprised of Bria-IMT™ + checkpoint inhibitor is expected to provide a new therapeutic option in patients who currently have no effective therapeutic options. The parallel development of BriaDx™ (companion diagnostic) by BriaCell, as a strategy to identify those patients most likely to respond to Bria-IMT™, may eventually lead to even higher response rates — potentially substantially higher than currently achievable by other treatments for breast cancer.

 

BriaCell is in contact with several large pharmaceutical companies for potential collaborations for the development of a combination therapy with Bria-IMT™ and immune checkpoint inhibitors, and already has in place a collaboration with Incyte Corporation. We will continue to pursue these discussions with the goal of using Bria-IMT™ in combination with checkpoint inhibitors. This will also help increase the visibility of our therapy and may lead to additional funding sources for future clinical trials.

 

Competition

 

Currently available therapeutic options for breast cancer offer some hope for patients, but there is much room for improvement. Comparable studies looking primarily at second line or later treatment are shown in the Table. Evaluating response rates (partial and complete responses = ORR), progression free survival (PFS) and overall survival (OS) from clinical trials in similar subjects with metastatic or recurrent breast cancer indicate that response rates range from 6.9% up to 59%, depending on the population studied and the intervention (median 24%). PFS ranges from 8 weeks to 12 months (median 5 months) and OS from 6 months to 31 months (median 13 months).

 

 

8 Gragert, Loren, Abeer Madbouly, John Freeman, and Martin Maiers. 2013. “Six-Locus High Resolution HLA Haplotype Frequencies Derived from Mixed-Resolution DNA Typing for the Entire US Donor Registry.” Human Immunology.

9 Mariotto AB, Etzioni R, Hurlbert M, Penberthy L, Mayer M. Estimation of the Number of Women Living with Metastatic Breast Cancer in the United States. Cancer Epidemiol Biomarkers Prev. 2017 Jun;26(6):809-815.

10 Kotsakis A, Ardavanis A, Koumakis G, Samantas E, Psyrri A, Papadimitriou C. Epidemiological characteristics, clinical outcomes and management patterns of metastatic breast cancer patients in routine clinical care settings of Greece: Results from the EMERGE multicenter retrospective chart review study. BMC Cancer. 2019 Jan 18;19(1):88.

11 Gragert, Loren, Abeer Madbouly, John Freeman, and Martin Maiers. 2013. “Six-Locus High Resolution HLA Haplotype Frequencies Derived from Mixed-Resolution DNA Typing for the Entire US Donor Registry.” Human Immunology.

12 Momenimovahed Z, Salehiniya H. Epidemiological characteristics of and risk factors for breast cancer in the world. Breast Cancer (Dove Med Press). 2019 Apr 10;11:151-164. SEER Cancer Statistics Factsheets: Female Breast Cancer. National Cancer Institute. Bethesda, MD; American Cancer Society. Breast Cancer Facts & Figures 2017-2018. Atlanta: American Cancer Society, Inc. 2017.

 

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Table: Studies evaluating second-line or later treatment options. Data depict an unpredictable response rate to treatment ranging from 6.9-59%, therefore establishing and confirming the opportunity for Bria-IMT™.

 

Study  Treatment & Design  # of Pts   ORR   PFS/TTP  OS
Perez13  Paclitaxel Monotherapy   212    21.5%  4.7 mo  12.8 mo
Seidman14  Gemcitabine Monotherapy   160    26%      
Zelek15  Vinorelbine Monotherapy   40    25%     6 mo
Licchetta16  Cyclophosphamide and megestrol acetate   29    31%  7.4 mo  13.4 mo
Harvey17  Docetaxel Monotherapy 60 mg/m2   122    22.1%  12.7 wk  10.6 mo
   Docetaxel Monotherapy 75 mg/m2   146    23.3%  15.0 wk  10.3 mo
   Docetaxel Monotherapy 100 mg/m2   139    36.0%  16.6 wk  12.3 mo
Rivera18  Docetaxel Monotherapy q3wk   59    35.6%  5.7 mo  18.3 mo
   Docetaxel Monotherapy qwk   59    20.3%  5.5 mo  18.6 mo
Gradishar19  ABI-007 (Nab paclitaxel)   229    33%  23.0 wk  65.0 wk
   Paclitaxel Monotherapy   225    19%  16.9 wk  55.7 wk
   ABI-007 (Nab paclitaxel) 2nd line   132    27%  20.9 wk  56.4 wk
   Paclitaxel Monotherapy 2nd line   136    13%  16.1 wk  46.7 wk
Perez20  Ixabepilone Monotherapy   126    11.5%  3.1 mo  8.6 mo
Leyland-Jones21  Trastuzumab with paclitaxel   32    59%  12.2 mo   
von Minckwitz22  Trastuzumab with capecitabine   78    48.1%  8.2 mo  25.5 mo
   Capecitabine Monotherapy   78    27.0%  5.6 mo  20.4 mo
Verma23  Trastuzumab emtansine   495    43.6%  9.6 mo  30.9 mo
   lapatinib plus capecitabine   496    30.8%  6.4 mo  25.1 mo
Geyer24  Lapatinib plus capecitabine   163    22%  8.4 mo   
   Capecitabine Monotherapy   161    14%  4.4 mo   
Bartsch25  Capecitabine and trastuzumab   40    20%  8 mo  24 mo
Blackwell26  Lapatinib Monotherapy   148    6.9%  8.1 wk  39.0 wk
   Lapatinib with trastuzumab   148    10.3%  12.0 wk  51.6 wk

 

 

13 Perez, E. A., Vogel, C. L., Irwin, D. H., Kirshner, J. J. & Patel, R. Multicenter Phase II Trial of Weekly Paclitaxel in Women With Metastatic Breast Cancer. J. Clin. Oncol. 19, 4216–4223 (2001).

14 Seidman, A. D. Gemcitabine as single-agent therapy in the management of advanced breast cancer. Oncology (Williston Park). 15, 11–4 (2001).

15 Zelek, L. et al. Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma. Cancer 92, 2267–72 (2001)

16 Licchetta A, Correale P, Migali C, Remondo C, Francini E, Pascucci A, Magliocca A, Guarnieri A, Savelli V, Piccolomini A, Carli AF, Francini G. Oral metronomic chemo-hormonal-therapy of metastatic breast cancer with cyclophosphamide and megestrol acetate. J Chemother. 2010 Jun;22(3):201-4.

17 Harvey, V. et al. Phase III Trial Comparing Three Doses of Docetaxel for Second-Line Treatment of Advanced Breast Cancer. J. Clin. Oncol. 24, 4963–4970 (2006).

18 Rivera, E. et al. Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer. Cancer 112, 1455–1461 (2008).

19 Gradishar WJ. Taxanes for the treatment of metastatic breast cancer. Breast Cancer (Auckl). 2012;6:159-71.

20 Perez, E. A. et al. Efficacy and Safety of Ixabepilone (BMS-247550) in a Phase II Study of Patients With Advanced Breast Cancer Resistant to an Anthracycline, a Taxane, and Capecitabine. J. Clin. Oncol. 25, 3407–3414 (2007).

21 Leyland-Jones, B. et al. Pharmacokinetics, Safety, and Efficacy of Trastuzumab Administered Every Three Weeks in Combination With Paclitaxel. J. Clin. Oncol. 21, 3965–3971 (2003). Only 41% of patients had prior systemic chemotherapy

22 von Minckwitz G et el. Trastuzumab beyond progression: overall survival analysis of the GBG 26/BIG 3-05 phase III study in HER2-positive breast cancer. Eur J Cancer. 2011 Oct;47(15):2273-81. Prior therapy limited to trastuzamab alone or in combination with a taxane.

23 Verma, S. et al. Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer. N. Engl. J. Med. 367, 1783–1791 (2012).

24 Geyer, C. E. et al. Lapatinib plus Capecitabine for HER2-Positive Advanced Breast Cancer. N. Engl. J. Med. 355, 2733–2743 (2006).

25 Bartsch, R. et al. Capecitabine and Trastuzumab in Heavily Pretreated Metastatic Breast Cancer. J. Clin. Oncol. 25, 3853–3858 (2007).

26 Blackwell, K. L. et al. Randomized Study of Lapatinib Alone or in Combination With Trastuzumab in Women With ErbB2-Positive, Trastuzumab-Refractory Metastatic Breast Cancer. J. Clin. Oncol. 28, 1124–1130 (2010).

 

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MBC treated with second or higher lines of therapy has a very poor prognosis and few effective therapies that consistently induce long-term remission,27 which indicates the market demand and clinical need for new and improved therapeutic drugs and treatment options in order to improve these response outcomes and patient survival rates. Thus, Bria-IMT™ has the potential to induce long-term remission, especially in combination with immunotherapies. Current treatment of MBC is outlined in the Figure, which illustrates different therapeutic treatment options and drugs used upon diagnoses from biopsy and identification of breast cancer biomarkers.28

 

 

 

Figure Current treatment paradigm for metastatic breast cancer and comparison between different treatment strategies and combination therapies dependent upon biomarker identification and activity within the breast cancer signaling pathway.

 

Of patients treated with trastuzumab for MBC, one study showed that 241/331 (72%) progressed within 27 months (32% per year) with median survival of 13-14 months (CI 10-15 months).29 This indicates the high unmet need in this patient population which should facilitate regulatory review of novel therapies such as Bria-IMT™.

 

While there are approximately 36 different biotech companies working to create an effective breast cancer vaccine, a significant gap remains in the effectiveness and safety of second or higher lines of therapy. The most studied targeted immunotherapy, Neuvax (Galena), a HER2 peptide vaccine, failed a Phase III trial, but there is encouraging data to support at least three ongoing clinical trials combining trastuzumab with HER2 epitope immunogens.30 The NCI randomized trial adding PANVAC (a poxviral-based immunogen) to docetaxel increased the median PFS from 3.9 months to 7.9 months and is to be used as a basis for larger, more sophisticated clinical trials.31 An immunogen targeting a carbohydrate antigen, globo-H, was associated with improved PFS, but only in the subset able to mount antibody responses.32 A Johns Hopkins breast cancer trial using a breast cancer cell line transfected with the gene for GM-CSF has not been positive but, using the same cell line with trastuzumab, 40% of patients enjoyed clinical benefit (CR+PR+stable) at one year.33 Finally, the study of targeted cancer immunotherapies in combination with other therapies is receiving much attention, particularly combination with checkpoint inhibitors.34

 

 

27 Dawood S, Broglio K, Ensor J, Hortobagyi GN, Giordano SH. Survival differences among women with de novo stage IV and relapsed breast cancer. Ann Oncol. 2010 Nov; 21(11):2169–74; Bonotto M, Gerratana L, Iacono D, Minisini AM, Rihawi K, Fasola G, Puglisi F. Treatment of Metastatic Breast Cancer in a Real-World Scenario: Is Progression-Free Survival With First Line Predictive of Benefit From Second and Later Lines? Oncologist. 2015 Jul;20(7):719-24; Kotsakis A, Ardavanis A, Koumakis G, Samantas E, Psyrri A, Papadimitriou C. Epidemiological characteristics, clinical outcomes and management patterns of metastatic breast cancer patients in routine clinical care settings of Greece: Results from the EMERGE multicenter retrospective chart review study. BMC Cancer. 2019 Jan 18;19(1):88.

28 NCCN Guidelines Version 2.2019, 07/02/2019 © 2019 National Comprehensive Cancer Network (NCCN®).

29 Rossi, V.; Nole, F.; Redana, S.; Adamoli, L.; Martinello, R.; Aurilio, G.; Verri, E.; Sapino, A.; Viale, G.; Aglietta, M.; Montemurro, F., Clinical outcome in women with HER2-positive de novo or recurring stage IV breast cancer receiving trastuzumab-based therapy. Breast 2014, 23 (1), 44-9.

30 Mittendorf, E. A.; Peoples, G. E., Injecting Hope—A Review of Breast Cancer Vaccines. Oncology (Williston Park) 2016, 30 (5), 475-81, 485.

31 Heery, C. R.; Ibrahim, N. K.; Arlen, P. M.; Mohebtash, M.; Murray, J. L.; Koenig, K.; Madan, R. A.; McMahon, S.; Marte, J. L.; Steinberg, S. M.; Donahue, R. N.; Grenga, I.; Jochems, C.; Farsaci, B.; Folio, L. R.; Schlom, J.; Gulley, J. L., Docetaxel Alone or in Combination With a Therapeutic Cancer Vaccine (PANVAC) in Patients With Metastatic Breast Cancer: A Randomized Clinical Trial. JAMA Oncol 2015, 1 (8), 1087-95.

32 Huang, C.; Yu, A.; Tseng, L., Randomized phase II/III trial of active immunotherapy with OPT-822/OPT-821 in patients with metastatic breast cancer. J Clin Oncol 2016, 34 (15).

33 Chen, G.; Gupta, R.; Petrik, S.; Laiko, M.; Leatherman, J. M.; Asquith, J. M.; Daphtary, M. M.; Garrett-Mayer, E.; Davidson, N. E.; Hirt, K.; Berg, M.; Uram, J. N.; Dauses, T.; Fetting, J.; Duus, E. M.; Atay-Rosenthal, S.; Ye, X.; Wolff, A. C.; Stearns, V.; Jaffee, E. M.; Emens, L. A., A feasibility study of cyclophosphamide, trastuzumab, and an allogeneic GM-CSF-secreting breast tumor vaccine for HER2+ metastatic breast cancer. Cancer Immunol Res 2014, 2 (10), 949-61.

34 McArthur, H. L.; Page, D. B., Immunotherapy for the treatment of breast cancer: checkpoint blockade, cancer vaccines, and future directions in combination immunotherapy. Clin Adv Hematol Oncol 2016, 14 (11), 922-933.

 

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There is a large number of therapies with other mechanisms of action in development for this indication which could limit uptake as other therapies are being rolled out, even if they could be used in combination with Bria-IMT™. We plan to develop the clinical data for Bria-IMT™ and use this information to reach out to oncologists seeking additional therapeutic options for their patients. We will include in this effort a physician education campaign targeting the oncologists most likely to treat metastatic breast cancer. As these physicians become more aware of the data regarding Bria-IMT™ in breast cancer, we will make sure they also understand how best to use Bria-IMT™ in combination with other therapies that have complementary of synergistic mechanisms of action. This will also come from future clinical studies focusing on combination therapy.

 

There are several other approaches to developing targeted breast cancer immunotherapies. These include using peptide cocktails, a triple peptide regimen, recombinant HER2, antigen-pulsed dendritic cells, DNA immunogens, whole cell allogeneic GM-CSF secreting SKBR3 or T47D cells, an (HLA)-A2/A3-restricted immunogenic peptide derived from the HER2 protein, oxidized mannan-MUC1, and personalized peptide immunogens.

 

Among the most promising results in patients with advanced disease have been using whole-cell preparations, particularly if the cells are engineered to express GM-CSF. We are taking this approach and capitalizing on positive initial results with Bria-IMT™ monotherapy in difficult to treat patients using a regimen that both limits regulatory T cell activity (using low dose cyclophosphamide pre-treatment) and boosts the immune response (using post-dose alpha interferon in the inoculation sites). The combination with pembrolizumab is a logical extension of our findings where 21 of 23 MBC patients had demonstrable PD-L1 expression on the circulating tumor cells (CTCs) and/or circulating cancer-associated macrophage-like cells (CAMLs). The overall strategy to include an adaptive design, once the initial milestones have been met, to enroll additional patients for product registration, will allow rapid progression of the best therapeutic option to a Biologics License Application (BLA).

 

Products/Pipeline

 

Bria-IMT™

 

Bria-IMT™, BriaCell’s lead candidate, is a whole-cell immunotherapy undergoing clinical testing in patients with metastatic breast cancer who have failed prior lines of therapy. BriaCell has been conducting a Phase I/IIa clinical trial of Bria-IMT™, in combination with immune checkpoint inhibitors such as pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.). The combination study is listed in ClinicalTrials.gov as NCT03328026 under FDA-approved BB-IND 10312 under protocol BRI-ROL-001 at 3 clinical sites: St. Joseph Heritage Healthcare, Santa Rosa, California, United States; University of Miami/Sylvester at Plantation, Plantation, Florida, USA; Cancer Center of Kansas (CCK), Wichita, Kansas, USA. Subsequent to the establishment of a collaboration with Incyte Corporation, this study has been modified to evaluate the combination of the Bria-IMT™ with INCMGA00012 (a PD-1 inhibitor) and epacadostat (an indoleamine dioxygenase (IDO) inhibitor).

 

BriaCell has achieved proof of concept based on data from a Phase I/IIa study of Bria-IMT™ in advanced breast cancer patients. In essence, BriaCell obtained evidence that patients with certain HLA molecules also present in Bria-IMT™ have a higher likelihood of responding to the Bria-IMT™ regimen with tumor shrinkage, which is consistent with results from a molecular analysis of Bria-IMT™ conducted by BriaCell.

 

Positive Proof of Concept

 

  Bria-IMT™ has been evaluated in a regimen including pre-dose low-dose cyclophosphamide (to reduce immune suppression), intradermal inoculation with 20-50 million irradiated Bria-IMT™ cells 2-3 days later, with subsequent intradermal inoculation with interferon-α2b ~2 & 4 days later. This is known as the Bria-IMT™ regimen. Both were single arm studies, so there were no untreated patients for comparison.
  BriaCell has evaluated the Bria-IMT™ regimen in two Phase I/IIa studies of Bria-IMT™ in advanced breast cancer patients.
  There were 4 evaluable patients treated in one study (Study SVMC #01-026) and 23 patients treated in another study (Study WRI-GEV-007) with this regimen with cycles every 2 weeks for the first month and then monthly. They were heavily pre-treated with a median of 4 prior systemic therapy regimens.
  In the SVMC #01-026 study, treatment was limited to 6 cycles over 5 months. Four post-menopausal white women were enrolled aged between 58.7 and 73 years. Three had breast cancer and one had Her2+ ovarian cancer. All had failed at least one prior systemic therapy.
  These patients received between 4 and 6 cycles of treatment on protocol. One patient had an additional 13 cycles off protocol.
  The only adverse events that occurred in more than one patient were itch and rash at the inoculation sites. No deaths were reported during this study. There were four serious adverse events (SAEs) in 3 patients with one (transient urticaria, grade 3) judged probably related to treatment. All SAEs were manageable with community practice therapies.
  The Bria-IMT™ regimen was able to elicit delayed-type hypersensitivity (DTH) responses in all patients. DTH is a measure of cell-mediated immunity. This response involves the interaction of T-cells, monocytes, and macrophages. This reaction is caused when CD4+ Th1 helper T cells recognize foreign antigen in a complex with the Class II HLA molecule on the surface of antigen-presenting cells. These can be macrophages or dendritic cells that secrete monokines such as IL-12 and IL-15, which stimulates the proliferation of additional CD4+ Th1 cells. CD4+ T cells secrete other cytokines including IL-2 and interferon gamma, inducing the further release of other Th1 cytokines, thus mediating the immune response. This results also in the activation of CD8+ T cells which destroy target cells on contact, and activated macrophages which produce hydrolytic enzymes.
  The DTH response involves the interaction of T-cells, monocytes, and macrophages. This reaction is caused when CD4+ Th1 helper T cells recognize foreign antigen in a complex with the Class II HLA molecule on the surface of antigen-presenting cells. These can be macrophages or dendritic cells that secrete monokines such as IL-12 and IL-15, which stimulates the proliferation of additional CD4+ Th1 cells. CD4+ T cells secrete other cytokines including IL-2 and interferon gamma, inducing the further release of other Th1 cytokines, thus mediating the immune response. This results also in the activation of CD8+ T cells which destroy target cells on contact and activated macrophages which produce hydrolytic enzymes.
  One patient (A002) had a partial response with regression of breast lesions, resolution of lung and soft tissue lesions, and improvement of stability of bone lesions. She completed therapy and 3 months after her last Bria-IMT™ inoculation, imaging studies identified regrowth of tumor notably in the breast, lung, and brain. After consultation with the FDA, the patient was treated off-protocol which also produced tumor regression, including the resolution of brain metastases. The HLA-DRB3 allele of patient A002 matched with that of SV-BR-1-GM and the HLA-DRB1 allele of patient A002 also matched that of SV-BR-1-GM. Her tumor was grade II (moderately differentiated). One other patient on this study (B001) with a grade II tumor had disease limited to bony metastases. She did not have measurable disease but was felt to progress on study.
  Median time to tumor progression was 144 days (range 64 – 223 days) for the initial round of treatment. Overall survival was more than 33 months in all patients except B001 (7 months).
  In the WRI-GEV-007 study, patients were treated with a median of 3 cycles of therapy (range 1-8). Time on study and the reason for terminating treatment are shown in the Figure: Study BRI-ROL-001 - Time on Study.
  The Bria-IMT™ regimen was able to elicit both cellular immune responses (as evidenced by delayed-type hypersensitivity (DTH) responses in 85% of patients evaluated) and antibody responses (present in 58% of patients evaluated).
  The most common adverse events seen were local irritation at the inoculation sites. There were no drug-related serious adverse events.
  Several patients showed evidence of anti-tumor activity of the Bria-IMT™ regimen in spite of their being heavily pre-treated advanced breast cancer patients. Specifically, one patient (designated 01-002) had regression or disappearance of 20 lung metastases, but stable disease in liver metastases (as the liver metastases were the target lesions, she did not qualify as a partial response). She displayed a robust DTH response, had a grade I tumor and matched Bria-IMT™ at 2 HLA loci. One patient (05-002) had a reduction in the size of a breast lesion but progression of a liver lesion and did not meet criteria for a partial response. She also displayed a robust DTH response, had a grade II tumor and matched Bria-IMT™ at 2 HLA loci. One patient (01-005) had a marked reduction in cutaneous involvement but developed restrictive cardiomyopathy (unrelated to study drug) with subsequent mortality. She had a grade III (poorly differentiated) tumor and matched Bria-IMT™ at one HLA locus. She was not on study long enough to be evaluated for her response. The per cent changes in tumor size for the patients with measurable disease for whom data is available is shown in Figure: Study BRI-ROL-001 - Tumor Responses and Serum Markers.

 

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  Patients 01-002, 05-002 and 01-005 who showed objective evidence of tumor shrinkage all matched the Bria-IMT™ cell line at least at one HLA locus and all had evidence of DTH responses to Bria-IMT™ and/or the parent cell line (SV-BR-1 – the breast cancer cell line from which Bria-IMT™ was derived). Patients who did not develop a DTH response did not show evidence of tumor shrinkage.
  Patients 01-002 and 05-002 had grade I/II tumors. Both of them also had 2 HLA matches with Bria-IMT™. Two other patients with grade II tumors (patient 03-001 and 06-001) had stable disease on the study and were also considered to have received clinical benefit from the treatment. (Clinical benefit was defined as some evidence of tumor shrinkage (including a mixed response with shrinkage of some tumors but progression of others, as for 05-002) with over 90 days on study; or as stable disease, a partial response or a complete response as per RECIST criteria). Neither 03-001 or 06-001 had HLA matches with Bria-IMT™, suggesting that HLA matching may not be required for clinical benefit in patients with grade I/II tumors. Thus, 4 of the 6 patients with grade I/II tumors exhibited clinical benefit. One of the remaining patients showed no evidence of an immune response as evaluated by DTH. Thus, 4 of the 5 grade I/II patients able to develop an immune response, as noted by DTH, exhibited clinical benefit. Changes in tumor size and time on study for these patients is shown in Figure: Study BRI-ROL-001 – Time on Study and Figure: Tumor Responses and Serum Markers.
  These preliminary data indicate that the Bria-IMT™ regimen in advanced breast cancer patients is well tolerated, able to elicit an immune response and induce reduction in tumor burden.
  Another phase I/IIa study was initiated evaluating the combination of the Bria-IMT™ regimen with Keytruda® (pembrolizumab). This combination combines the induction of an immune response by Bria-IMT™ (putting the foot on the gas of the immune response) with the ability of Keytruda® to block the PD-1 – PD-L1 immune checkpoint (take the foot off the brakes of the immune response).
  Eleven patients with advanced breast cancer (median of 4 prior systemic therapy regimens) have been treated with this regimen with cycles every 3 weeks for a median of 3 cycles (range 1 – 9 cycles).
  Two patients had evidence of tumor regression, both of whom had robust immune responses (as measured by DTH) to Bria-IMT™. Both of them had grade II tumors. One matched Bria-IMT™ at 2 HLA types (06-005) while the other did not match Bria-IMT™ at any HLA types (06-001, who “rolled over” from the WRI-GEV-007 study where she had stable disease), suggesting that the Bria-IMT™ regimen, when given in combination with a PD-1 inhibitor, may be able to induce tumor regression without an HLA match especially in patients with grade I/II tumors. One additional patient (06-004) in this study had a grade II tumor and was noted to have stable disease. The other 7 patients treated had grade III tumors (poorly differentiated). Thus, all 3 of the patients with grade I/II tumors showed evidence of clinical benefit. Changes in tumor size for patients with grade I/II tumors, and time on study for these patients, is shown across the clinical program in the Figure: Study BRI-ROL-001 – Time on Study and Figure: Tumor Responses and Serum Markers.
  Following the establishment of a collaboration with Incyte Corporation, this study is being altered to evaluate the combination of the Bria-IMT™ regimen with INCMGA00012 (anti-PD-1 antibody similar to Keytruda®) and epacadostat (inhibitor of indoleamine dioxygenase (IDO), which suppresses the immune response). The combination with Keytruda® has been discontinued but will be resumed in an investigator-initiated study.
  The data confirms the “HLA Matching Hypothesis” and supports BriaCell’s strategy for the development of Bria-OTS™, BriaCell’s first personalized off-the-shelf immunotherapy for advanced breast cancer.

 

Table: Study BRI-ROL-001 – Combination Therapy Patient Characteristics

 

Patient Characteristics (11 total) 

No HLA Allele Matches

(n=4)

  

1+ HLA Allele Matches

(n=7)

  

2+ HLA Allele Matches

(n=5)

  

All Patients

(n=11)

 
Age  61 ± 11   62 ± 9   62 ± 12   62 ± 9 
Median Prior Systemic Regimens  6 (range 2-10)   4 (range 1-14)   4 (range 1-14)   4 (range 1-14) 
% ER+ or PR +   75%   67%   50%   70%
% Her2/neu +   50%   50%   50%   50%
% Triple Negative   0%   0%   0%   0%
% grade I/II   25%   29%   20%   27%

 

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Figure: Study BRI-ROL-001 – Delayed Type Hypersensitivity to Bria-IMT™

 

Rationale: Delayed-type hypersensitivity (DTH) is a good marker of cellular (T cell) immune responses. The Positive control (Candida) or 1x106 irradiated Bria-IMT™ cells were injected intra-dermally in the forearm (DTH) with 5x106 irradiated Bria-IMT™ cells injected in 4 sites in the upper back and thighs (Inoculation Site). 2±1 days later, these sites were assessed for erythema and induration. The largest response (diameter of erythema or induration) for each patient is shown. The insert notes the mean DTH responses seen.

 

Conclusion: All the patients with follow-up information developed DTH to Bria-IMT™, despite anergy to test antigens (Candida) in some patients, indicating potent immunogenicity of Bria-IMT™. The most robust responses were seen in patients with objective tumor regression (06-001 and 06-005).

 

Figure: Study BRI-ROL-001 – Time on Study

 

Blue indicates roll-over subjects time on Study 1.

 

Green indicates time on combination therapy

Arrows à indicate ongoing in the study.

 

Results: To date treatment has been generally well tolerated with no serious adverse events (AEs) or withdrawals due to AEs.

 

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Figure: Study BRI-ROL-001 - Tumor Responses and Serum Markers

 

Tumor Markers in Patients on Combination Therapy

 

    06-001 06-004 06-005 06-007
Baseline CEA 167.8 0.2 139.2 1.8
Initial Eval CEA

48.15

(-68%)

1.55

15.21

(-89%)

5.35
Cycle 9 CEA   28.55  
Baseline 15-3 196.5 93.4 1886 62.4
Initial Eval 15-3

114.9

(-42%)

114.4

533.7

(-72%)

60.3
Cycle 9 15-3     666.2  

 

  Patient 06-001: ER+/HER2-, grade II, Hepatic Metastases, Robust DTH, no HLA Matches with Bria-IMT™
  Patient 06-005: ER+/HER2-, grade II, Adrenal and Dural Metastases, Robust DTH, two HLA matches with Bria-IMT™

 

Figure: BRI-ROL-001 - Characteristics of Responders

 

Patient 06-001 Patient 06-005
  73-year-old woman   70-year-old woman
  Ductal adenocarcinoma diagnosed April 2010   Ductal adenocarcinoma diagnosed Dec 2009
  Stage IV Tumor grade II – Moderate   Stage IV Tumor grade II – Moderate
  ER+, PR-, HER2-   ER+, PR-, HER2 1+
  7 prior chemotherapy regimens with 9 agents + Avastin   12 prior regimens with 16 agents (13 chemo 3 hormonal)
  Did not match at any HLA loci   Matched at 2 HLA loci – HLA-C and HLA-DRB3
  Entered the monotherapy study with 4 liver metastases   Entered the monotherapy study with adrenal, bone and dural metastases
  One of the best immune responders (DTH)   One of the best immune responders (DTH)
  Stable disease on monotherapy (slight increase in tumor sizes)   70% reduction in target adrenal and orbital metastases, with resolution of proptosis, with stable or improved dural metastases
  25% reduction in the sum of diameters of target liver metastases on combination therapy   Reduction also in tumor markers CEA (-89%) and 15-3 (-72%)
  Reductions also in tumor markers CEA (-68%) and 15-3 (-42%)   She transitioned to treatment with the Incyte-supplied PD-1 inhibitor (INCMGA00012) and had complete resolution of the orbital tumor, which had been causing proptosis (Figure: Orbital Tumor Response to Bria-IMT™ + Immune Checkpoint Inhibitor)

 

Figure: Orbital Tumor Response to Bria-IMT™ + Immune Checkpoint Inhibitor

 

 

About Bria-IMT™

 

Developed and characterized by a team of dedicated scientists and clinicians, Bria-IMT™ (SV-BR-1-GM) is a targeted immunotherapy being developed for the treatment of breast cancer. Bria-IMT™ is a genetically engineered human breast cancer cell line with features of immune cells and clinically applied as a targeted immunotherapy.

 

In short, Bria-IMT™ immunotherapy is a genetically engineered human breast cancer cell line derived from a grade II tumor which activates the immune system to attack and destroy breast cancer tumors.

 

Mechanism of Action of Bria-IMT™: The mechanism of action of Bria-IMT™ is currently under investigation. It is likely that the expression of certain breast cancer antigens (proteins expressed in breast cancer cells) in Bria-IMT™ generates strong T cell and potentially antibody and responses – resulting in recognition and destruction of cancerous cells.35

 

 

35 Lacher M.D., Bauer G. Fury B., Graeve S., Fledderman E.L., Petrie T.D., Coleal-Bergum D.P., Hackett T., Perotti N.H., Kong Y.Y., Kwok W.W., Wagner J.P., Wiseman C.L., and Williams W.V. SV-BR-1-GM, a Clinically Effective GM-CSF- Secreting Breast Cancer Cell Line, Expresses an Immune Signature and Directly Activates CD4+ T Lymphocytes. Frontiers in Immunology 2018; 9: Article 776.

 

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Bria-IMT™ is designed to secrete granulocyte/macrophage-colony stimulating factor (GM-CSF), a factor that stimulates components of the immune system. Specifically, GM-CSF activates dendritic cells, the cells that start immune responses. These activated dendritic cells then activate T cells, a key component of the immune system, to recognize the tumor cells as foreign, and eliminate them. To amplify this action, we have combined Bria-IMT™ with other immune system activators including cyclophosphamide (used in low doses to reduce immune suppression), and interferon-α, a cytokine that further activates the immune system. We believe this approach of simultaneous activation of the immune system via different pathways will improve the immune system response to attack and destroy cancer cells.

 

Using BriaCell’s novel technology platform and our strong R&D capabilities, we plan to develop Bria-OTS™, a personalized off-the-shelf immunotherapy for breast cancer, and similar immunotherapy cell lines for other cancer indications.

 

Bria-OTS™ is under development as an off-the-shelf personalized immunotherapy for advanced breast cancer.
   
The concept for Bria-OTS™ comes from BriaCell’s work with Bria-IMT™, where we noted that if a patient “matches” Bria-IMT™ in their HLA type, they were more likely to respond.
   
HLA molecules are the molecules that start immune responses but are polymorphic – i.e. they are different in different people, although some people will share the same HLA molecules (referred to as “HLA alleles” or “HLA types”).

 

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Bria-OTS™ is made from cell lines that are genetically engineered to expresses the immune boosters GM-CSF and interferon-α, as well as specific HLA types (a.k.a. alleles).
   
Different cell lines are being pre-manufactured to express different HLA types matching >99% of the overall breast cancer patient population.
   
Using the BriaDx™, a companion diagnostic test performed on the patient’s saliva, the suitable personalized treatment will be selected for each patient for administration.
   
This approach allows personalized treatment without the need for personalized manufacturing. Additionally, it saves time, and skips expensive and complicated manufacturing procedures associated with other personalized treatments.
   
Bria-OTS™ cell lines are being engineered with the goal of transferring them to production in 2020 and commencing clinical evaluation in 2021 (expected authorization by FDA and expected first patient to be dosed in 2021) with safety and efficacy data expected to be released during 2021 and 2022.

 

Bria-OTS™ Immunotherapy Matches ~99% of the Breast Cancer Population

 

The calculation of matching >99% of the population is as follows: Four cell lines will be pre-manufactured, each carrying two (2) HLA-A and two (2) HLA-DRB3/4/5 alleles, for a total of eight HLA-A and seven HLA-DRB3/4/5 alleles (Tables 1 and 2). The HLA-DRB3, HLA-DRB4, and HLA-DRB5 genes occupy essentially the same locus, with presence of one gene excluding the presence of another. The minimum percentage of patients covered by at least one (1) HLA-match was estimated using published allele frequencies (Tables 1 and 2)1. Furthermore, data from the 2010 Census were used to estimate allele matches in different races.

 

Table 1 (HLA-A)

 

   Alleles in Bria-OTS  African
American
   White   Asian 
US Census 2010 (Frequencies)      12.6%   72.4%   4.8%

 

Sub-Population     AAFA   EURCAU   JAPI 
      Frequency*   Frequency*   Frequency* 
HLA-A  A*02:01   12.3%   27.6%   14.8%
HLA-A  A*01:01   4.7%   16.5%   1.0%
HLA-A  A*03:01   8.4%   14.0%   0.9%
HLA-A  A*24:02   2.5%   8.5%   35.3%
HLA-A  A*11:01   1.4%   6.1%   8.7%
HLA-A  A*68:01   4.0%   3.2%   0.2%
HLA-A  A*23:01   11.0%   2.0%   0.1%
HLA-A  A*33:03   5.2%   0.3%   6.5%
                   
At least 1 HLA-A match  Sum of allele frequencies:   49.4%   78.0%   67.5%
At least 1 HLA-A match  Per individual (2n):   74.4%   95.2%   89.4%

 

*HLA allele frequencies by Gragert et al.1 AAFA, African American; EURCAU, European Caucasian, JAPI, Japanese. Percentages of “At least 1 HLA-A match” are higher per individual than the sum (ΣAFHLA-A) of the allele frequencies (AF) since allele frequencies refer to one chromosome set (1n), with each individual having two chromosome sets (2n). The per-individual (2n) “phenotype frequencies” (PF) indicating the percentage of individuals with at least one HLA-A match with the exogenous HLA-A alleles from the Bria-OTS cell lines were calculated as follows: PFHLA-A = 1 - (1 - ΣAFHLA-A)2, whereby (1-ΣAFHLA-A)2 is the probability that an individual does not carry at least 1 of the HLA-A alleles. Example: for African American, PFHLA-A = 1 - (1 - ΣAFHLA-A)2 = 1 – (1 – 49.4%)2 = 74.4%.

 

Table 2 (HLA-DRB3/4/5)

 

   Alleles in Bria-OTS  African
American
   White   Asian 
US Census 2010 (Frequencies)      12.6%   72.4%   4.8%

 

Sub-Population     AAFA   EURCAU   JAPI 
      Frequency*   Frequency*   Frequency* 
DRB3/4/5  DRB4*01:01   18.3%   31.2%   38.4%
DRB3/4/5  DRB3*02:02   27.2%   18.2%   10.4%
DRB3/4/5  DRB3*01:01   13.4%   14.9%   6.3%
DRB3/4/5  DRB5*01:01   14.4%   13.5%   8.7%
DRB3/4/5  DRB3*03:01   9.6%   4.9%   7.5%
DRB3/4/5  DRB5*01:02   0.2%   0.7%   9.7%
DRB3/4/5  DRB5*02:02   1.5%   1.6%   0.7%
At least 1 HLA-DRB345 match  Sum of allele frequencies:   84.6%   85.0%   81.6%
At least 1 HLA-DRB345 match  Per individual (2n):   97.6%   97.8%   96.6%

 

*HLA allele frequencies by Gragert et al.1 AAFA, African American; EURCAU, European Caucasian, JAPI, Japanese (lowest HLA-DRB3/4/5 allele frequency among Asians). Allele and phenotype frequencies (2n) were calculated as described for Table 1.

 

Estimate for “at least 1 HLA match” frequency

 

Gragert et al.1 reported the 100 most frequent haplotype frequencies. For EURCAU (European Caucasian), 27 of the 56 (8 x 7) Bria-OTS [HLA-A]-[HLA-DRB345] combinations were represented among these 100 haplotypes. Since the haplotype frequencies at the lower end of the 100 most frequent alleles were close to zero, it was assumed that for 50% (27/56 is ~50%) of the Bria-OTS [HLA-A]-[HLA-DRB345] combinations both the HLA-A and the HLA-DRB345 allele are on the same haplotype and for 50% of the combinations, the alleles are independently inherited. Also taking the Census 2010 frequencies for African American (12.6%), White (72.4%), and Asian (4.8%) populations into account (Tables 1 and 2), the “at least 1 HLA match (HLA-A or HLA-DRB345)” frequency for the entire US population is estimated as follows:

 

African American

 

12.6% * (97.6% + (1 - 97.6%) * (1 - (1 - (0.5 * 49.4%))2)) = 12.4%

 

Census HLA-DRB345 Not DRB345 HLA-A, via allele frequency

 

White

 

72.4% * (97.8% + (1 - 97.8%) * (1 - (1 - (0.5 * 78.0%))2)) = 71.8%

 

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Asian

 

4.8% * (96.6% + (1 - 96.6%) * (1 - (1 - (0.5 * 67.5%))2)) = 4.7%

 

Sum frequency = 89.0% (digits taken into account that were above not shown)

 

This frequency represents 12.6% (African American) + 72.4% (White) + 4.8% (Asian) = 89.8% of the entire US Population

 

Assuming the remaining 100% - 89.9% = 10.1% of the US population has the same “at least 1 HLA match” frequency, the “at least 1 HLA match” frequency across the US is:

89.0% / 89.8% = 99.1%.

 

References

 

1. Gragert L, Madbouly A, Freeman J, Maiers M. Six-locus high resolution HLA haplotype frequencies derived from mixed-resolution DNA typing for the entire US donor registry. Hum Immunol. 2013;74(10):1313-1320.

 

 

BriaDx™

 

BriaDx™ is a diagnostic test that BriaCell is developing to identify the patients most likely to respond to Bria-IMT™. Currently, BriaDx™ includes HLA typing of the patients as patients having HLA alleles also present in Bria-IMT™ appear to have a higher likelihood of responding to the Bria-IMT™ regimen with tumor regression (“shrinkage”). Additional markers of potential diagnostic use are being developed based on the expression of specific biomarkers in the responder (i.e. biomarkers which identify the patients for which Bria-IMT™ immunotherapy appears more effective) vs the non-responder patients from clinical studies of Bria-IMT™ in advanced breast cancer patients.

 

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Blood and including circulating tumor cells from the patients is analyzed using cutting-edge technologies including gene expression analysis and assessment of the levels of antibodies predicted to bind to Bria-IMTTM.

 

The insights gained from biomarker studies conducted to date have provided us with a solid basis for the development of Bria-OTS™, an off-the-shelf personalized immunotherapy which would match over 99% of patients with advanced breast cancer.

 

BriaDx™ is being developed to help understand which patients are most likely to respond to Bria-IMT™ targeted immunotherapy. Based on the proposed mechanism of action of Bria-IMT™ (see Figure below) HLA molecules play a key role inducing cellular immune responses to Bria-IMT™ which boosts the patient’s immune response to their cancer.

 

proposed mechanism of action of Bria-IMT™

 

 

HLA molecules are polymorphic, in that they are different in different individuals, but shared by some individuals (similar to eye color). Based on our clinical data to date, we hypothesize that patients with HLA alleles also present in Bria-IMT™ have a higher likelihood of responding to the Bria-IMT™ regimen with tumor regression (“shrinkage”). Therefore, BriaDx™, a companion diagnostic test, determines the patients’ HLA types.

 

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Available Clinical Data for Treatment with the Bria-IMT™ Regimen

 

BriaCell conducted three Proof of Concept clinical trials, one using parental SV-BR-1 cells and the other two using Bria-IMT™ (i.e., genetically engineered SV-BR-1 cells – producing GM-CSF also called SV-BR-1-GM), in metastatic (i.e., Stage IV) breast cancer patients who had failed prior treatments. The patients were treated with the Bria-IMT™ regimen according to the following schedule, and the results are summarized below.

 

 

First Proof of Concept Trial36

 

  The initial study was conducted between May 1999 and August 2003 at St. Vincent Medical Center in Los Angeles, California, USA under Food and Drug Administration (FDA) Investigational New Drug (IND) numbers BB-IND 2749 and BB-IND 10312. The endpoints of the study were:
     
    Primary endpoint
     
      1. To assess clinical toxicity and feasibility of administration of SV-BR-1
         
    Secondary endpoints
     
      1. To evaluate clinical responses, if any, after 3 vaccines and at the conclusion of study, i.e., after inoculation #6; as well as time to progression, and survival
      2. To assess immune responses, if any, as measured by delayed type hypersensitivity (DTH) skin tests
         
  Patients initially received low-dose cyclophosphamide to reduce immune suppression, followed by intradermal inoculation with the irradiated parental cell line (SV-BR-1 cells) with subsequent local injections of granulocyte-macrophage colony stimulating factor (GM-CSF) to boost the response
  N = 14 late stage, treatment-refractory breast cancer patients
  No significant adverse treatment-associated events, well tolerated
  Median Overall Survival = 12.1 months

 

Second Proof of Concept Trial37

 

  This study was conducted between December 2004 and June 2006 at St. Vincent Medical Center in Los Angeles, California, USA under Food and Drug Administration (FDA) Investigational New Drug (IND) number BB-IND 10312, protocol number SVMC #01-026. The endpoints were:
     
    Primary endpoint
     
      1. To assess clinical toxicity and feasibility of administration of SV-BR-1 with accrual of at least 9 evaluable patients
         
    Secondary endpoints
     
      1. To evaluate clinical responses, if any, after 3 vaccines and at the conclusion of study, ie, after inoculation #6; as well as time to progression, and survival
      2. To assess immune responses, if any, as measured by delayed type hypersensitivity (DTH) skin tests, enzyme-linked immunosorbent assays (ELISAs) for antibody to tumor vaccine, and flow-activated cell sorter assay for vaccine antigen-reactive T-cells
         
  Used Bria-IMT™ (genetically engineered SV-BR-1 cells – producing GM-CSF) with pre-dose, low dose cyclophosphamide and post-dose local interferon-α to boost the response (the Bria-IMT™ regimen).
  N = 4 late stage, treatment-refractory (3 breast cancer (2 grade II and 1 grade III), and 1 ovarian cancer) patients
  No significant adverse treatment-associated events, well tolerated
  Median Overall Survival = 35 months
  One robust responder with >90% regression during treatment, subsequent relapse (upon halting treatment) responded to re-treatment
  This patient matched Bria-IMT™ at a key HLA type (HLA-DRB3) and had a grade II tumor

 

Third Proof of Concept Trial

 

Thirty patients were screened, 24 enrolled and 23 dosed in the Phase I/IIa study.

 

 

36 Wiseman, C. L. & Kharazi, A. Phase I Study with SV-BR-1 Breast Cancer Cell Line Vaccine and GMCSF: Clinical Experience in 14 Patients. Open Breast Cancer J. 2, 4–11 (2010).

37 Wiseman, C. L. & Kharazi, A. Objective Clinical Regression of Metastatic Breast Cancer in Disparate Sites after Use of Whole-Cell Vaccine Genetically Modified to Release Sargramostim. Breast J. 12, 475–480 (2006).

 

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  This study was conducted between April 2017 and December 2018 under FDA-approved BB-IND 10312, protocol number WRI-GEV-007. Six study sites participated: St. Joseph Heritage Healthcare, Santa Rosa, California, United States; Florida Cancer Center, Plantation, Florida, USA; University of Miami/Sylvester at Plantation, Plantation, Florida, USA; Cancer Center of Kansas (CCK), Wichita, Kansas, USA; Thomas Jefferson University, Philadelphia, Pennsylvania, USA; Providence Regional Medical Center, Everett, Washington, USA. This study is listed on ClinicalTrials.gov as NCT03066947. The endpoints were:
     
    Primary Endpoint:
     
      The number, frequency, duration, and relation of toxicity events to SV-BR-1-GM, as defined by Common Terminology Criteria for Adverse Events (“CTCAE”) and additional tests
         
        Secondary Endpoints:
         
      Objective response rate (ORR), defined as complete response (CR) or partial response (PR) per RECIST and iRECIST response criteria
         
      Non-progressive rate, defined as CR, PR or stable disease (SD) per RECIST and iRECIST
         
      Durability of response, by evaluating those patients eligible to complete the optional treatments from 9-12 months.
         
  The Bria-IMT™ regimen included pre-dose low-dose cyclophosphamide (to reduce immune suppression), intradermal inoculation with 20-50 million irradiated Bria-IMT™ cells 2-3 days later, with subsequent intradermal inoculation with interferon-α2b ~2 & 4 days later.
     
  The 23 patients treated with this regimen received cycles every 2 weeks for the first month and then monthly. They were heavily pre-treated with a median of 4 prior systemic therapy regimens.
     
  Patients were treated with a median of 3 cycles of therapy (range 1-8).
     
  The Bria-IMT™ regimen was able to elicit both cellular immune responses (as evidenced by delayed-type hypersensitivity (DTH) responses in 85% of patients evaluated) and antibody responses (present in 58% of patients evaluated).
     
  There were no serious, unexpected, drug-related AEs

 

Most patients who dropped out did so due to worsening of their underlying disease.

 

Specifically, 14 patients terminated participation due to progressive disease, 4 withdrew, 3 due to mortality (unrelated to study drug), and 2 terminated participation due to adverse events (both judged unrelated to study drug).

 

  Tumor shrinkage was seen in 3 of 17 patients who match with Bria-IMT ™ at 1 or more HLA locus (type), including in 2 of 5 patients who match Bria-IMT™ at 2 or more HLA loci (types) further supporting our “HLA Matching Hypothesis”, and the development of Bria-OTS ™ to single match over 99% and double match ~90% of the patient population.
     
  Six patients had grade I/II tumors. Of these, 2 had definite tumor regression as noted above. Both matched Bria-IMT™ at 2 HLA loci. An additional 2 had stable disease, which is included in the usual definition of clinical benefit.
     
  Effectiveness also depends on the ability of the patient to develop an immune response to Bria-IMT™ as measured by DTH to the Bria-IMT™ or to the parental cell line (SV-BR-1). Across both “monotherapy” studies (SVMC #01-026 and WRI-GEV-007), a positive DTH response was noted in 22 patients while 5 were not responsive.
     
  Results are shown in the tables here, combining the second and third proof of concept studies which both used Bria-IMT™ in an identical regimen.

 

Tumor Shrinkage in Studies SVMC #01-026 and WRI-GEV-007 Based on HLA Matching to Bria-IMT™ and Immune Response to Treatment

 

Patients  HLA Match   Tumor Shrinkage   Tumor Shrinkage in Immune Responders 
N=6   ≥2    50%   75%
N=20   ≥1    20%   27%
N=7   0    0%   0%
All Patients N=27        15%   18%

 

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Tumor Shrinkage and Clinical Benefit in Studies SVMC #01-026 and WRI-GEV-007 Based on Tumor Grade

 

Patients  Grade I/II   Tumor Shrinkage   Tumor Shrinkage or Stable Disease 
All Patients N=27   8    50%   63%
Immune Responders (as measured by DTH)               
Immune Responders N=22   7    57%   71%

 

*Immune response measured by DTH testing. There were 5 non-responders based on the DTH responses and 22 responders.

 

  Bria-IMT™ was dosed in 27 patients (4 in 2004-2006, 23 in 2017-2018) as the Bria-IMT™ regimen alone.
     
  Bria-IMT™ has been very well tolerated (over 100 doses given to date).
     
  Tumor regression was seen in patients who were able to mount an immune response and matched Bria-IMT™ at HLA types confirming our main hypothesis and supporting using HLA typing as a marker to predict who is most likely to respond.
     
  BriaCell continues to monitor their clinical trials proposing that BriaDx™ would include HLA typing as well as other potential biomarkers (such as the ability to mount a DTH response) to identify the patients most likely to respond to the Bria-IMT™ regimen.

 

Time on Study and Reason for Withdrawal in Study WRI-GEV-007

 

Figure: Time on study is shown in days with the Investigator’s reason for removing the patient from the study. Green arrows indicate the patient transitioned onto the pembrolizumab combination study (BRI-ROL-001).

 

Target Lesion and Total Lesion Responses in Study WRI-GEV-007

 

 

 

Figure: The best response at the follow-up imaging evaluation is shown as the sum of diameters of the target lesions (left) or the sum of diameters of all measurable lesions for which data is available (right). Note that the usual criteria for progressive disease (increase of the sum of diameters of target lesions of 20% or more) was not met in all patients who were classified as progressive disease. Those denoted with an * also had new lesions appear.

 

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Development of Additional Immunotherapy Cell Lines

 

  Based on these observations, BriaCell is extending this technology to other types of cancer by developing additional immunotherapy cell lines.
     
  Cell lines currently being genetically engineered include a Prostate Cancer cell line (novel immunotherapy cell line 1 or NICL1), a non-small cell lung cancer cell line (NICL2) and a melanoma cell line (NICL3).
     
  Initial steps in the genetic engineering have been completed with subsequent steps planned for 2021.
     
  IND filings for these NICLs are anticipated starting in 2022.

 

Protein Kinase C Delta (PKCδ) Inhibitors

 

Definitions

 

Term  Abbreviation  Description
BC106, BJE6-106  N/A  PKC δ inhibitor; reference compound; owned by BriaCell
PKC  Protein Kinase C  Family of proteins with enzymatic activity modulating various cellular functions
PKCα  Protein Kinase C alpha  Alpha isozyme of PKC
PKC δ  Protein Kinase C delta  Delta isozyme of PKC
Ras  RAt Sarcoma virus  Family of proteins regulating cell proliferation
K-Ras  Kirsten RAt Sarcoma virus  A particular Ras family member, often activated by mutation in cancer
MTS assay     An in vitro assay indicating metabolic activity of cells. Used to assess numbers of viable (alive) cells.
TGFβ  Transforming growth factor beta  Extracellular factor with both pro- and anti-tumorigenic properties. Immunosuppressive.

 

Overview

 

The delta isoform of the Protein Kinase C family (PKC δ) is implicated in a multitude of cellular responses to external and internal stimuli, playing both pro- and anti-tumorigenic roles. In contrast to PKCα, PKCδ does not seem to be required for survival of normal cells. In PKCδ knockout mice, mild lymphoproliferation was observed, but overall, PKCδ inhibition is well tolerated at the organismal level. BriaCell scientists develop small-molecule PKC δ inhibitors for use in those situations where PKC δ carries out pro-tumorigenic functions. Preliminary data suggest that PKC δ inhibition may be particularly beneficial in a subset of cancers with oncogenic Ras or with otherwise activated Ras signaling, for instance in endometrial cancers with estrogen-induced K-Ras stabilization (Figure 1). In particular, PKC δ inhibition may be of therapeutic use in cancers dependent on Ras signaling for proliferation, as shown in vitro for lung cancer. BriaCell, through its subsidiary Sapientia Pharmaceutials, Inc., uses structural information of Rottlerin, a PKC δ inhibitor with modest activity, and Staurosporine, a potent but nonspecific PKC inhibitor, to develop a series of “hybrid” compounds (Figure 2). This rational design approach is envisioned to yield molecules with, compared to Rottlerin, enhanced activity yet retained PKC δ-selectivity.  

 

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Strategy and Results

 

PKCδ inhibition was achieved with small molecules using a pharmacophore model based on Staurosporine and Rottlerin. One of the most promising molecules based on this approach, BC106 (BJE6-106), presents an IC50 for PKCδ inhibition of ~50 nM and is ~1000-fold more selective for PKCδ than for PKCα (Figure 2). In cellular and animal model studies, BC106 shows effective anti-proliferative and anti-tumor activity, but this molecule is not water soluble, hence not appropriate as a drug candidate. Efforts to improve water solubility have been initiated, with a series of compounds undergoing testing in in vitro kinase and cell-based assays.

 

To develop PKCδ inhibitors BriaCell affiliates started with two molecules known to have PKC-inhibitory properties: Staurosporine and Rottlerin. Multiple chemical manipulations and testing resulted in BC106, one of the Company’s most effective compounds to-date. Staurosporine is a well-known Protein Kinase C (PKC) inhibitor with anti-cancer activity, while Rottlerin, also known as Mallotoxin, opens potassium channels that have been used to induce apoptosis. Rottlerin has also been shown to be an immunosuppressive agent, affecting multiple oncogenic pathways. Although some reports claim that Rottlerin does not act primarily via PKCδ inhibition, BriaCell’s data supports Rottlerin-derived molecules as viable tumor suppressors.

 

The Company’s strategy for compound synthesis is based on a hitherto unexplored design concept, wherein functional moieties of two natural products known to strongly inhibit PKCδ – Rottlerin and Staurosporine – have been “intellectually cut” from each natural product and then covalently joined to make a novel, chimeric scaffold as illustrated in Figure 2. The Company’s synthetic analogs, in essence, combine the bottom benzopyran moiety of Rottlerin and chemically join that to the indolyl carbazole moiety of Staurosporine. Further, new chimeric scaffolds are synthesized in a novel, convergent modular fashion allowing for the rapid assembly and testing of many derivatives.

 

 

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Rottlerin was initially used because this molecule inhibits purified PKCδ at an IC50 of 3-5 μM in vitro, and in cultured cells with an IC50 of 5 μM. Rottlerin is relatively more selective for PKCδ than for PKCα (PKCδ IC50:PKCα IC50 ≈ 1:30). BriaCell further advanced its pharmacophore model using the Rottlerin-based prototype chimeric structure in combination with Staurosporine by incorporating protein structural data for the novel class PKCs. This strategy produced a 2nd generation of PKCδ inhibitors with the “head” group resembling that of Staurosporine and the other domains conserved from the Rottlerin scaffold to preserve isozyme specificity. A second generation successful product is represented by BC128, which has an IC50 of 4 μM for PKCδ (similar to Rottlerin), and better isozyme selectivity (IC50 of >120 μM for PKCα). BC128 showed anti-tumor cell activity in vitro and in vivo (Figure 3).

 

 

 

BC106, the BriaCell’s most-recent “lead” compound, produces substantial cytotoxicity against multiple human tumor lines at nM concentrations (10-40 times lower than Rottlerin or BC128). BC106 dramatically inhibited the clonogenic capacity of RAS-mut tumor cell lines after as little as 12 h. exposure (Figure 4). BC106 is 1000-fold more selective for PKCδ than for PKCα. The latter is an important finding because inhibition of PKCα is generally toxic to all cells (normal and malignant) and would make BC106 non-tumor-targeted.

 

Approximately 40% of melanomas harbor NRAS mutations and there is no effective RAS-targeted treatment available for this subgroup. BriaCell affiliates have demonstrated that NRAS-mutant melanoma cells were highly sensitive to PKCδ siRNA knock-down and to BC106 at nM concentrations (Figure 5). Clonogenic assays demonstrated that irreversible inhibition of proliferation required as little as 12 hours of exposure to Rottlerin or BC106 (Figure 4).

 

BriaCell affiliates also assessed the effects of PKCδ inhibition on breast tumor growth and survival in a xenograft human breast cancer stem cell model. As shown in Figure 6, PKC δ inhibition prevented tumor grown and promoted the survival of the animals evaluated over the course of 300 days (note that the vehicle treated animals all died within the first 20 days of the study).

 

Furthermore, PKC δ inhibition also inhibited the growth of neuroendocrine cells (Figure 7).

 

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Summary and Outlook

 

Early-Stage Preclinical Program

 

30% of all human malignancies display activating RAS mutations with another 60% showing over-activity of Ras-signaling pathways.38
   
BriaCell’s novel, proprietary PKCδ inhibitors have shown activity against multiple RAS transformed tumors.39
   
This target has an attractive safety profile based on in vivo studies and knock out mouse studies.40
   
PKCδ also has potential activity as an immunotherapeutic by blocking TGFβ signaling.41
   
PKCδ inhibitors are applicable to specific niche tumor types which provide an accelerated clinical development plan.
   
Structural aspects of first-generation inhibitor rottlerin and staurosporine (pan-PKC inhibitor) were combined to create second generation inhibitor KAM1
   
Third generation inhibitors such as BC-106 have improved potency and selectivity.
   
Fourth generation inhibitors are under development to optimize their drug-like characteristics.
   
PKCδ inhibitors lack endothelial cell cytotoxicity & PKCδ deficient mice develop normally and are fertile → No marked intrinsic toxicity by inhibiting PKCδ.
   
Candidate selection is anticipated in 2021.

 

 

38 Prior IA, Lewis PD, Mattos C. A comprehensive survey of Ras mutations in cancer. Cancer Res. 2012 May 15; 72(10): 2457–2467

39 Xia, S., Forman, L. W. & Faller, D. V. Protein Kinase Cδ Is Required for Survival of Cells Expressing Activated p21RAS. J. Biol. Chem. 282, 13199–13210 (2007); Chen, Z. et al. Protein kinase Cδ inactivation inhibits cellular proliferation and decreases survival in human neuroendocrine tumors. Endocr. Relat. Cancer 18, 759–71 (2011); Xia, S., Chen, Z., Forman, L. W. & Faller, D. V. PKCδ survival signaling in cells containing an activated p21Ras protein requires PDK1. Cell. Signal. 21, 502–508 (2009); Liou, J. S., Chen, C.-Y., Chen, J. S. & Faller, D. V. Oncogenic Ras Mediates Apoptosis in Response to Protein Kinase C Inhibition through the Generation of Reactive Oxygen Species. J. Biol. Chem. 275, 39001–39011 (2000); Liou, J. S., Chen, J. S. & Faller, D. V. Characterization of p21Ras-mediated apoptosis induced by protein kinase C inhibition and application to human tumor cell lines. J. Cell. Physiol. 198, 277–294 (2004); Chen, C. Y., Liou, J., Forman, L. W. & Faller, D. V. Differential regulation of discrete apoptotic pathways by Ras. J. Biol. Chem. 273, 16700–9 (1998); Chen, C. Y. & Faller, D. V. Direction of p21ras-generated signals towards cell growth or apoptosis is determined by protein kinase C and Bcl-2. Oncogene 11, 1487–98 (1995); Chen, C. Y. & Faller, D. V. Phosphorylation of Bcl-2 protein and association with p21Ras in Ras-induced apoptosis. J. Biol. Chem. 271, 2376–9 (1996); Chen, C.-Y., Liou, J., Forman, L. W. & Faller, D. V. Correlation of genetic instability and apoptosis in the presence of oncogenic Ki-Ras. Cell Death Differ. 5, 984–995 (1998); Chen, C. Y. et al. The recruitment of Fas-associated death domain/caspase-8 in Ras-induced apoptosis. Cell Growth Differ. 12, 297–306 (2001).

40 Miyamoto A, Nakayama K, Imaki H, Hirose S, Jiang Y, Abe M, Tsukiyama T, Nagahama H, Ohno S, Hatakeyama S, Nakayama KI. Increased proliferation of B cells and auto-immunity in mice lacking protein kinase Cdelta. Nature. 2002 Apr 25;416(6883):865-9.

41 Wermuth PJ, Addya S, Jimenez SA. Effect of Protein Kinase C delta (PKC-δ) Inhibition on the Transcriptome of Normal and Systemic Sclerosis Human Dermal Fibroblasts In Vitro. PLoS ONE, November 2011, Volume 6, Issue 11, e27110; PMCID: PMC3214051; Li Z, Jimenez SA. Protein Kinase C δ and c-Abl Kinase Are Required for Transforming Growth Factor β Induction of Endothelial–Mesenchymal Transition In Vitro. Arthritis and Rheumatism, Vol. 63, No. 8, August 2011, pp 2473–2483 PMCID: PMC3134600; Bujor AM, Asano Y, Haines P, Lafyatis R, Trojanowska M. The c-Abl Tyrosine Kinase Controls Protein Kinase C δ –Induced Fli-1 Phosphorylation in Human Dermal Fibroblasts. Arthritis & Rheumatism, Vol. 63, No. 6, June 2011, pp 1729–1737. PMCID: PMC3381734

 

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Early Phase Programs

 

BriaCell has recently filed provisional patent applications describing:

 

  Coronavirus Immunotherapy
  Antibody-Based Treatment of Infectious Diseases
  Novel Therapeutics for Cancer
  Novel Immune Therapies for Multiple Disease Indications
  Novel Treatment and Diagnosis of Coronavirus Disease

 

The Coronavirus Immunotherapy patent application, filed on April 10, 2020, entitled, “INDUCING IMMUNE RESPONSES BY TRANSFORMING CANCER CELLS INTO ANTIGEN-PRESENTING CELLS”, is based on molecular analyses of the Company’s lead anti-tumor product candidate. Antigen-presenting cells are the cells that typically start immune responses. BriaCell’s whole-cell immunotherapies are designed to stimulate the immune system to recognize and destroy the patient’s tumors by acting as antigen-presenting cells that stimulate the patient’s cancer-cell-recognizing immune cells. The new patent application by BriaCell scientists expands on this paradigm by proposing additional cellular therapeutics designed to activate immune cells recognizing SARS-CoV-2 (the coronavirus causing COVID-19) antigens. The patent application seeks protection for, among others, new whole-cell therapeutics and methods for their use. These are designated “Novel Immunotherapy Cell Lines (NICL1 – Prostate Cancer, NICL2 – non-small cell lung cancer, NICL3 – melanoma, NICL-CoV-2)”. IND filings for NICL1, NICL2 and NICL3 are anticipated to be made in 2022. Each IND filing requires an additional ~US$1,000,000.

 

The Antibody-Based Treatment of Infectious Diseases patent application, filed on April 20, 2020, entitled, “COMPUTER-GUIDED DESIGN OF ANTIBODIES INCLUDING NEUTRALIZING SARS-CoV-2 BINDING AGENTS”, outlines compositions and methods for generating antibodies to neutralize SARS-CoV-2 (the coronavirus causing COVID-19) using computer-based simulation technology. Such antibodies are envisioned to prevent and treat the life-threatening symptoms of COVID-19. The use of computer simulation creates highly targeted antibodies by improving pre-existing antibodies. The improvements include, but are not limited to, creating higher affinity and/or specificity antibodies to the SARS-CoV-2 Spike protein (the protein which the virus uses to infect cells) versus the unmodified antibody. The resulting therapeutic antibodies are expected to quickly and specifically recognize the SARS-CoV-2 virus, bind to it, and neutralize it. The patent application also provides compositions and methods, using similar technologies, for cancer-directed antibodies. The patent application seeks protection for the design of new therapeutic antibodies and methods for their use. These are designated “Antibodies for SARS-CoV-2”. If a suitable sponsor or partner is found for this program, an IND filing for this treatment is anticipated to be made in 2022 and requires an additional ~US$1,000,000.

 

The patent application for Novel Immune Therapies for Multiple Disease Indications, filed on May 15, 2020, entitled, “MULTI-VALENT IMMUNOSTIMULATORS FOR INFECTIOUS DISEASES, AUTOIMMUNE DISEASES, ALLERGIC DISEASES AND CANCER”, describes a platform to generate multi-valent reagents carrying an antigen (such as an antigen from SARS-CoV-2) and delivering it to immune cells such as dendritic cells, a type of antigen-presenting cell crucial for the induction and modulation of immune responses. The expected effect is a targeted therapy envisioned to selectively destroy infectious agents or cancer cells with minimal negative effect on normal cells. This may mean less severe side effects for the treated patients compared to other therapies. The technology also has uses for autoimmune diseases and allergic diseases. The Company cautions that these novel therapeutics are still under early-stage research and development and is not making any express or implied claims as to their success in cancer treatment or commercial viability. The patent application seeks protection for, among others, the design of new therapeutics and methods for their use. These are designated “Novel ImmunoStimulators (NIS-CoV-2)”. If a suitable sponsor or partner is found for this program, an IND filing for this treatment is anticipated to be made in 2022 and requires an additional ~US$1,000,000.

 

The Company cautions that COVID-19 therapeutic development is still under early-stage research and development and is not making any express or implied claims that it has the ability to treat, prevent or eliminate the COVID-19 virus at this time.

 

The patent application for Novel Therapeutics for Cancer, filed on April 23, 2020, is entitled, “METHODS FOR INDUCING AND ENHANCING ANTI-CANCER IMMUNE RESPONSES USING NOVEL MOLECULAR CONSTRUCTS”. It outlines the development and use of multi-specific binding reagents that simultaneously bind to an immune cell and a cancer cell, or just to a cancer cell, and activate the immune system against the cancer cells. The novel binding reagents are designed to act, among others, as potent immune cell activators/immune checkpoint inhibitors without the toxicity of current checkpoint inhibitors. The expected effect is a highly targeted therapy envisioned to selectively destroy cancer cells without affecting normal (non-cancerous) cells. This may mean less severe side effects for the treated cancer patients compared to alternative therapies. The Company cautions that these novel therapeutics are still under early-stage research and development and is not making any express or implied claims as to their success in cancer treatment or commercial viability. The patent application seeks protection for, among others, the design of new therapeutics and methods for their use. These are designated “Bria-TILs-Rx”. IND filings for Bria-TILs-Rx for the treatment of prostate cancer and epithelial and glandular cancer, respectively, are anticipated to be made in 2022 and require an additional ~US$1,000,000 each.

 

The patent application for Novel Treatment and Diagnosis of Coronavirus Disease, filed on June 22, 2020, entitled “MULTI-VALENT DECOY RECEPTORS FOR DIAGNOSIS AND/OR TREATMENT OF CORONAVIRUS INFECTION”, describes a platform to generate multi-valent molecular constructs (decoy receptors) that have the potential to prevent coronaviruses including the SARS-CoV-2 virus (the virus that causes Coronavirus Disease 2019 (COVID-19)) from entering (infecting) healthy host cells. Multi-valent constructs described in the patent application are believed to have both therapeutic and diagnostic potential, the latter in the context of determining whether a patient has developed coronavirus-specific antibodies. The Company cautions that these novel therapeutics are still under early-stage research and development and is not making any express or implied claims as to their success in treatment or commercial viability. The patent application seeks protection for, among others, the design of new therapeutics and diagnostics and methods for their use.

 

On October 28, 2020, BriaCell entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Health and Human Services, as represented by National Cancer Institute (NCI). Under the CRADA, the National Cancer Institute and BriaCell Therapeutics Corp. will work together to conduct preclinical studies to develop and test BriaCell Therapeutic Corp.’s proprietary Bria-OTS cellular immunotherapy as a treatment for cancer to improve and broaden applicability of this therapeutic strategy. Under the terms of the CRADA, BriaCell will provide funding (totaling $433,400 over three years) to support the project. The NCI estimates that 1.3 person-years of effort per year will be required to complete the CRADA research which includes the development of a mouse model of this therapeutic strategy. BriaCell and NCI will be using their combined expertise in tumor immunology, molecular biology and development of cellular therapies to design studies which are intended to trigger the immunologic pathways necessary to create potent immune responses against cancer. The goal of the collaboration is to develop novel therapeutics for future clinical collaborations, allowing cancer patients to potentially benefit from potent and personalized cancer immunotherapy.

 

Mechanism of Action of Bria-IMT™ and Bria-OTS™

 

The mechanism of action of Bria-IMT™/Bria-OTS™ is currently under investigation.

 

We believe that Bria-IMT™/Bria-OTS™ activates the patient’s immune system to recognize tumor cells and destroy them. We hypothesize that Bria-IMT™/Bria-OTS™ exerts its action via the patient’s antigen-presentation system {i.e. the system that presents antigen material on the surface of cells for recognition by the T cells of the immune system as either self (i.e., safe) or foreign (i.e., to be destroyed)}. Specifically, Bria-IMT™/Bria-OTS, is thought to stimulate dendritic cells, a key component of the antigen-presenting system, to display certain immunogenic (i.e., immune response-generating) protein fragments to T cells, which activates the T cells to destroy the tumor cells either directly, or indirectly by inducing a humoral (antibody-generating) immune response. In addition, we also have shown that Bria-IMT™ is capable of directly stimulating. T cells thereby potentially adding additional therapeutic benefits. The latter property of Bria-IMT™ is the basis of the Bria-OTS™ project as it requires HLA matching between the therapeutic cells and the patient. 42

 

Our preliminary analyses have shown several up-regulated genes in Bria-IMT™ that encode proteins known to be immunogenic (i.e. immune response-generating), suggesting that Bria-IMT™ can stimulate the immune system against the cancer cells.

 

 

42 Lacher M.D., Bauer G. Fury B., Graeve S., Fledderman E.L., Petrie T.D., Coleal-Bergum D.P., Hackett T., Perotti N.H., Kong Y.Y., Kwok W.W., Wagner J.P., Wiseman C.L., and Williams W.V. SV-BR-1-GM, a Clinically Effective GM-CSF- Secreting Breast Cancer Cell Line, Expresses an Immune Signature and Directly Activates CD4+ T Lymphocytes. Frontiers in Immunology 2018; 9: Article 776.

 

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Bria-IMT™ is a human breast cancer cell line which expresses Her2/neu (a protein well known for its overexpression in breast cancer but also associated other epithelial malignancies including ovarian, pancreatic, colon, bladder and prostate cancers). Bria-IMT™ has been engineered to produce and secrete granulocyte/macrophage-colony stimulating factor (GM-CSF), a protein that promotes dendritic cell function, a key component of the immune system, and hence activates the immune system.

 

BRIA-IMT™ & BRIA-OTS™

 

Potential Mechanisms of Specific Immune Activation in Advanced Breast Cancer

 

 

 

1. Bria-IMT/OTS™ produces breast cancer antigens (proteins made by breast cancer cells)
   
2. Bria-IMT/OTS™ secretes GM-CSF which further promotes dendritic cell-based antigen presentation (boosts the response)
   
3. Breast cancer antigens are taken up by dendritic cells and “presented” to CD4+ and CD8+ T cells implicated in tumor destruction.
   
4. Bria-IMT/OTS™ directly stimulates cancer fighting CD4+ and CD8+ T cells (further boosts the response)
   
5. Bria-IMT/OTS™ biological activity depends on HLA matching of Bria-IMT/OTS™ and the patient

 

Clinical Trials

 

Phase I/IIA Combination Study of BRIA-IMT™ with Immune Checkpoint Inhibitors in Advanced Breast Cancer

 

The FDA approved the combination study of Bria-IMT™ with immune checkpoint inhibitors in advanced breast cancer (third line or later). The initial study used pembrolizumab (Keytruda, purchased by the Company as the Company does not have an agreement with Merck for the supply of Keytruda). The Company dosed 11 patients with this combination and no dose limiting toxicities were observed. Additionally, evidence of additive or synergistic activity was observed.

 

The combination with Keytruda was discontinued and the study was subsequently modified to use a combination of Bria-IMT with the Incyte PD-1 inhibitor (INCMGA00012) and epacadostat. In October, 2020, the Company announced that median OS of 13.3 months has been observed in this study and that median OS had reached 14 months in patients with Grade I/II tumors. The Company anticipates additional safety and efficacy data for the combination of Bria-IMT™ with INCMGA00012 and epacadostat to be released between the fourth quarter of 2020 and throughout 2021 and 2022.

 

One patient (06-005 noted above) transitioned from combined treatment of the Bria-IMT™ regimen with KEYTRUDA® to combination treatment with INCMGA00012. She has continued to have stable disease with further reduction in the size of some of her breast cancer nodules around the brain including disappearance of one nodule behind the left eye which was causing proptosis (pushing the eye forward). This nodule has completely disappeared and her eye has gone back into place.

 

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Rationale for the Combination Study of Bria-IMT™ with Immune Checkpoint Inhibitors

 

The immune checkpoint inhibitors such as anti-PD-1 antibodies have come to the forefront in the fight against cancer with substantial benefits for some patients. Recently, the significance of immune checkpoint inhibitors was recognized by the Nobel committee by awarding Dr. Tasuku Honjo and Dr. James P. Allison with the 2018 Nobel Prize in Physiology or Medicine (Scientists behind game-changing cancer immunotherapies win Nobel medicine prize), validating the Company’s decision to initiate a combination therapy with immune checkpoint inhibitors.

 

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Drs. Alison and Honjo independently, using different strategies, showed a new approach of treating patients by awakening certain cells of the immune system (T cells) to attack tumors. This new approach of treating patients with immune checkpoint inhibitors (such as anti-PD-1 antibodies), designed to overcome immune suppression in cancer patients, is revolutionizing the fight against cancer.

 

In 2010 a pre-clinical study by Dr. Allison’s group showed that combination with anti-PD-1 antibodies potentiated the tumor-destroying effect of melanoma cells engineered to produce granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system, compared to the treatment with the GM-CSF producing cells alone. Bria-IMT™, a breast cancer cell line, also produces GM-CSF. Bria-IMT™ has been shown to indirectly and directly stimulate T cells, and hence has displayed immune-activating properties. BriaCell has published these findings in a leading immunology journal. It is important to note that anti-PD-1 antibodies have not been shown to work on their own in breast cancer.

 

KEYTRUDA® (pembrolizumab)

 

Manufactured by Merck & Co., Inc., KEYTRUDA® (pembrolizumab) is a prescription medicine that may treat certain cancers by working with the immune system. It has been approved for the treatment of a number of cancer indications excluding breast cancer. The company is not a party to any agreements with Merck for the supply of KEYTRUDA.

 

A phase I/IIa study was initiated evaluating the combination of the Bria-IMT™ regimen with Keytruda® (pembrolizumab). This combination combines the induction of an immune response by Bria-IMT™ (putting the foot on the gas of the immune response) with the ability of Keytruda® to block the PD-1 – PD-L1 immune checkpoint (take the foot off the brakes of the immune response).
   
The study was planned to enroll up to 48 patients with the anticipated study completion date of December 31, 2020.

 

The endpoints of the study include:

 

Primary Outcome Measure:

 

  1. To evaluate the safety of SV-BR-1-GM as assessed by:

 

  a. Adverse Events (AEs), including Serious Adverse Events (SAEs)
  b. The Proportion of Patients with Abnormalities in Safety Laboratory Parameters
  c. Electrocardiograms (ECG) with measurement of the QT interval
  d. Changes in weight

 

Secondary Outcome Measures:

 

Evaluate the tumor response as assessed by:

 

  1. Objective response rate (ORR), defined as complete response (CR) or partial response (PR) per RECIST 1.1
  2. Non-progressive rate, defined as CR, PR or stable disease (SD) per iRECIST
  3. Durability of response

 

Patient eligibility requirements include:

 

  1. Have histological confirmation of breast cancer with recurrent and/or metastatic lesions, as per the investigational site, and have failed prior therapy.
  2. Patients with persistent disease and local recurrence must not be amenable to local treatment.
  3. For patients with metastatic disease:

 

  a. Human epidermal growth factor 2 (HER2) positive and estrogen receptor (ER) or progesterone receptor (PR) positive tumors: must be refractory to hormonal therapy (e.g., aromatase inhibitor, tamoxifen or fluvestrant) and previously treated with at least 2 regimens including at least two anti-HER2 agents (e.g., trastuzumab and pertuzumab).
  b. HER2 negative and either ER or PR positive tumors: must be refractory to hormonal therapy (e.g. aromatase inhibitor, tamoxifen or fluvestrant) and previously treated with at least 2 chemotherapy containing regimens.
  c. HER2 positive and ER and PR negative tumors: must have failed at least 2 regimens including at least two anti-HER2 agents (e.g., trastuzumab and pertuzumab).
  d. Triple Negative tumors: Must have exhausted other available therapies including prior treatment with a taxane and carboplatin.

 

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Patients with new or progressive breast cancer metastatic to the brain will be eligible provided:

 

  a. The brain metastases must be clinically stable (without evidence of progressive disease by imaging) for at least 4 weeks prior to first dose
  b. Must have received prior radiation therapy for brain metastases or be ineligible for radiation therapy
  c. There is no need for steroids and patients have not had steroids for at least 2 weeks
  d. No individual tumor size is >50 mm
  e. Tumor is not impinging on Middle Cerebral Artery/speech-motor strip
  f. If surgically debulked, must be healed from surgery and at least 3 weeks have elapsed since general anesthesia
  g. Patients consent to MRI studies at 3-4 week intervals until evidence of tumor regression on at least 2 imaging studies. In no case, will the interval between MRI studies be longer than 3 months. MRI studies may be introduced at any time should the patients develop new or clearly worsening symptoms and/or introduction of steroids

 

  2. Be 18 years of age or older and female
  3. Have expected survival of at least 4 months
  4. Have adequate performance status (ECOG 0-1)
  5. Have provided written informed consent

 

Eleven patients with advanced breast cancer (median of 4 prior systemic therapy regimens) have been treated with this regimen with cycles every 3 weeks for a median of 3 cycles (range 1 – 9 cycles).
   
Two patients had evidence of tumor regression, both of whom had grade II tumors and also had robust immune responses (as measured by DTH) to Bria-IMT™. One matched Bria-IMT™ at 2 HLA types while the other did not match Bria-IMT™ at any HLA types, suggesting that the Bria-IMT™ regimen, when given in combination with a PD-1 inhibitor, may be able to induce tumor regression without an HLA match especially in patients with grade I/II tumors. One other patient in this cohort had a grade II tumor and that patient had stable disease. Thus, of the 3 patients with grade I/II tumors treated with the combination of the Bria-IMT™ regimen with pembrolizumab, all 3 had evidence of clinical benefit as typically defined. Additional data available is shown in Table: Study BRI-ROL-001 Combination Therapy Patient Characteristics, Figure: BRI-ROL-001 - Delayed Type Hypersensitivity, Figure: BRI-ROL-001 - Time on Study, Figure: BRI-ROL-001 - Tumor Responses and Serum Markers and Figure: BRI-ROL-001 - Characteristics of Responders.
   
BriaCell purchased the Keytruda® for this study without a collaboration with Merck while pursuing other avenues to collaborate with a company that has an anti-PD-1 antibody and/or other immune checkpoint inhibitors to use in combination with the Bria-IMT™ regimen. BriaCell has obtained such an agreement with Incyte Corporation as noted below. Based on this, the combination therapy study (BRI-ROL-001) has been amended to evaluate combination of the Bria-IMT™ regimen with Incyte’s PD-1 inhibitor and epacadostat as noted below. The combination with Keytruda has been discontinued.

 

BriaCell & Incyte Collaboration and Supply Agreement

 

Non-exclusive clinical trial collaboration to evaluate the effects of combinations of novel clinical candidates

 

The clinical study will focus on (but not limited to) BriaCell’s lead candidate, Bria-IMT™, in combination with Incyte’s selected compounds for advanced breast cancer.
   
Incyte is providing compounds from its development portfolio, including INCMGA0012, an anti-PD-1 monoclonal antibody, and epacadostat, an IDO1 inhibitor, for use in combination studies with BriaCell’s lead candidate, Bria-IMT™.
   
Incyte is a global biopharmaceutical company focused on discovering and developing novel therapeutics in oncology and other serious diseases.
   
Incyte has a deep and rich pipeline in immuno-oncology with numerous molecular targets including PD-1, IDO, GITR, OX40, TIM-3, LAG-3, ARG, AXL/MER and PD-L1xCD137
   
The first 6 patients will receive the Bria-IMT™ regimen in combination with INCMGA00012. Once safety of the combination has been established, subsequent cohorts are planned to receive a triple combination of the Bria-IMT™ regimen with INCMGA00012 and epacadostat.
   
The design of the clinical study is shown below. Dosing of the novel combinations commenced in the fourth quarter of 2019.
   
The Company anticipates safety and efficacy data to be released between the fourth quarter of 2020 and during 2021 and 2022.

 

Additional data was presented at the American Association for Cancer Research (AACR) San Antonio Breast Cancer Meeting on December 10-11, 2020. The data presented summarized the clinical and pathological data of the Bria-IMT™ monotherapy (i.e. the Bria-IMT™ regimen alone) study and Phase I/IIa clinical study of Bria-IMT™ in combination with immune checkpoint inhibitors including pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.), and more recently, Incyte’s INCMGA00012 (by Incyte Corporation), in advanced breast cancer. 30 patients were treated with the Bria-IMT™ regimen (19 with the Bria-IMT™ regimen alone, 4 who began on the Bria-IMT™ regimen and transitioned to combination with a combination with Incyte’s INCMGA00012, and 7 with combination therapy with of Bria-IMT™ with KEYTRUDA®). 11 of those patients had moderately-well differentiated tumors. 70% of these patients who were able to develop an immune response showed disease control suggesting that the Bria-IMT™, with a molecular signature most closely related to moderately-well differentiated tumors, may result in disease control especially in patients with moderately-well differentiated tumors. These patients were very heavily pre-treated with a median of 7 prior systemic therapy regimens (including chemotherapy, biological and “targeted” therapy). The median Progression-free survival (PFS) of this cohort was 5.7 months in the monotherapy study, and 6.9 months in combination therapy. Of the group, there were 9 patients with evaluable lesions including 6 with stable disease and 2 with partial responses according to RECIST criteria. One patient with stable disease had a marked reduction in numerous non-target lesions. The data suggests clinical and survival benefit for patients with moderately-well differentiated tumors who were treated with the Bria-IMT™ regimen with or without check point inhibitors. Notably, the survival benefit was higher in the group that received the Bria-IMT™ regimen with check point inhibitors suggesting an additive or synergistic effect.

 

The median overall survival (OS) for the combined monotherapy and combination therapy was 12.5 months (data on 6 patients with moderately-well differentiated tumors). An OS of 7.2-9.8 months in similar patients with metastatic breast cancer in the third line setting has recently been published (Kazmi S, et al. “Overall survival analysis in patients with metastatic breast cancer and liver or lung metastases treated with eribulin, gemcitabine, or capecitabine.” Breast Cancer Res Treat. 2020). This suggests a potentially significant survival benefit for the patients treated with the Bria-IMT™ regimen alone or in combination with check point inhibitors.

 

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Marketing and Sales Strategy

 

The product will initially be marketed to oncologists who are well versed in the use of immunotherapy for cancer. Partnering with other pharma companies in order to market combinations with a number of drugs is also an option that we intend to pursue. This study will utilize a frozen formulation which consists of irradiated SV-BR-1-GM cells in viable freezing media. This formulation will permit stockpiling of the immunotherapy so that it can be sent on demand to clinical sites. The eventual goal is to reach all oncologists who treat late stage breast cancer either by direct outreach or by partnering with another company that has an established presence in the oncology space.

 

Other Commercial Considerations

 

There is a high unmet medical need in late stage breast cancer, providing potential for accelerated approval of Bria-IMT™. The FDA is interested in facilitating the availability of novel therapies of patients with unmet medical needs, especially those that can target the population most likely to respond. In addition, Bria-IMT™ may fit the description of an orphan drug, especially if HLA matching and/or limitation to grade I/II tumors is required. These two facts may help facilitate accelerated approval of Bria-IMT™.

 

Production and Marketing Plan

 

Bria-IMT™ cells grow in simple tissue culture media and are irradiated prior to inoculation. Bria-IMT™ manufacturing will be performed by Contract Manufacturing Organizations (CMOs). Recently we have been working with KBI Biopharma, Inc. who have developed a frozen formulation, where the cells are grown, harvested and irradiated followed by cryopreservation in a viable state. The cells are stockpiled and shipped directly to clinical sites for inoculation. Each lot of Bria-IMT™ is tested for potency (GM-CSF production), identity (HER2+ and ER/PR-) and adventitious agents to rule out contamination with infectious agents. To date, there have been no issues with these tests. Additional manufacturing facilities have been evaluated and may be enlisted as demand grows.

 

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Marketing will target oncologists who are well versed in the use of immunotherapy and cancer vaccines and especially breast cancer treatment centers. The initial target will be patients with metastatic or recurrent breast cancer who have failed at least 2 prior treatment regimens. We plan to develop the clinical data for Bria-IMT™ and use this information to reach out to oncologists seeking additional therapeutic options for their patients. We will include in this effort a physician education campaign targeting the oncologists most likely to treat metastatic breast cancer. As these physicians become more aware of the data regarding Bria-IMT™ in breast cancer, we will make sure they also understand how best to use Bria-IMT™ in combination with other therapies that have complementary of synergistic mechanisms of action. This will also come from the clinical studies described above focusing on combination therapy. Partnering with other pharma companies in order to market a number of drugs is also an option that we intend to pursue. Our eventual goal is to reach all oncologists who treat late stage breast cancer either by direct outreach or by partnering with another company that has an established presence in the oncology space.

 

License Agreements

 

On July 24, 2017, the Company entered into a definitive share exchange agreement (the “Share Exchange Agreement”) with its wholly-owned subsidiary, BriaCell Therapeutics Corp., and Sapientia Pharmaceuticals, Inc. including all the shareholders of Sapientia. Sapientia, a biotechnology company based in Havertown, PA, is developing novel targeted therapeutics for multiple indications including several cancers and fibrotic diseases.

 

Pursuant to the terms of the Share Exchange Agreement, BriaCell Therapeutics Corp agreed to acquire from the Sapientia shareholders all of the issued and outstanding shares in the capital of Sapientia in consideration to the Sapientia shareholders, pro rata, of an aggregate of 8,333 common shares in the capital of BriaCell (the “Transaction”), which were issued on September 5, 2017.

 

As part of the Transaction, BriaCell acquired the license agreement Sapientia entered into with Faller-Williams Technology (“FWT”), dated March 16, 2017, (the “License Agreement”), pursuant to which BriaCell acquired all rights, including composition of matter patents (the “PKCδ Patents”), and preclinical study data to a novel therapeutic technology platform, known as protein kinase C delta (PKCδ) inhibitors, which represents a unique, highly-targeted approach to treat cancer and to boost the immune system.

 

Pursuant to the License Agreement, FWT is eligible to receive certain milestone payments, including i) $5,000,000 upon the filing of each New Drug Application with the FDA with respect to products disclosed and/or described in the PKCδ Patents (the “PKCδ Products”); ii) $25,000,000 upon final approval of each New Drug Application by the FDA for the marketing of a PKCδ Product; iii) $1,000,000 upon the filing of each Marketing Authorization Application (“MAA”) with the Medicines and Healthcare Products Regulatory Agency of United Kingdom or the Committee for Medicinal Products for Human Use of the European Commission with respect to a PKCδ Product; and iv) $5,000,000 upon the final approval of each MAA with the Medicines and Healthcare Products Regulatory Agency of United Kingdom or the Committee for Medicinal Products for Human Use of the European Commission for the marketing of a PKCδ Product.

 

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FWT is eligible to receive certain royalty payments. Following the first commercial sale of a PKCδ Product in the United States, FWT shall receive i) 5% of worldwide net sales of PKCδ Products encompassed by one or more valid claims of the PKCδ Patents and/or improvements thereto, and ii) 2.5% of worldwide net sales from PKCδ Products not encompassed within one or more valid claims of the PKCδ Patents. Additionally, upon BriaCell’s receipt of marketing approval for a PKCδ Product from the FDA, the Medicines and Healthcare Products Regulatory Agency of United Kingdom, the Committee for Medicinal Products for Human Use of the European Commission or an equivalent authority, FWT shall receive minimum royalty payments of $250,000 per year.

 

Unless terminated earlier pursuant to the provisions therein, the License Agreement shall expire ten years after the last PKCδ Patent expires.

 

Intellectual Property

 

The proprietary nature of, and protection for, our current and/or any future product candidates, processes and know-how are important to our business as is our ability to operate without infringing on the proprietary rights of others, and to prevent others from infringing our proprietary rights. We seek patent protection in the United States and internationally for our current and future product candidates we may develop and other technology. In order to protect our proprietary technologies, we rely on combinations of application for patent and trade secret protection, as well as confidentiality agreements with employees, consultants, and third parties.

 

We have filed and own or have licensed all rights in the following pending patent applications and issued patents:

 

Filed with the United States Patent and Trademark Office (USPTO) on June 14, 2004, U.S. Patent No. 7,674,456 B2, includes claims to the following:

 

  1. Compositions comprising SV-BR cells
     
  2. Therapeutic methods of using said compositions

 

On February 27, 2017, BriaCell filed an international patent application under the Patent Cooperation Treaty (PCT) to further expand its intellectual property portfolio underlying the Company’s current and anticipated pipeline of whole-cell cancer immunotherapeutics including Bria-IMT™ and Bria-OTS™. The PCT application (PCT/US2017/019757) claims priority to two provisional patent applications filed by the Company with the USPTO in 2016. It, in essence, provides the framework for additional whole-cell cancer immunotherapeutics beyond Bria-IMT™ and strategies for patient-specific selection of the most likely effective whole-cell immunotherapeutic (BriaDx™). The PCT application entered the National Phase in the second half of 2018.

 

On July 24, 2017 BriaCell obtained the exclusive license to certain patents related to protein kinase C delta (PKCδ) inhibitor technology that includes patents to specific compounds, methods of using the compounds, and methods of assessing patients regarding the compounds. These patents include U.S. Patent No. 9,364,460 which issued June 14, 2016, U.S. Patent No. 9,572,793 which issued February 21, 2017, U.S. Patent No. 9,844,534 which issued December 19, 2017, and EP Patent No. 2897610 which issued January 10, 2018.

 

BriaCell has recently filed provisional patent applications at the USPTO as follows:

 

  1. Coronavirus Immunotherapy provisional patent application entitled “INDUCING IMMUNE RESPONSES BY TRANSFORMING CANCER CELLS INTO ANTIGEN-PRESENTING CELLS”, filed on April 10, 2020.
  2. Antibody-Based Treatment of Infectious Diseases provisional patent application, entitled, “COMPUTER-GUIDED DESIGN OF ANTIBODIES INCLUDING NEUTRALIZING SARS-CoV-2 BINDING AGENTS”, filed on April 20, 2020.
  3. Novel Therapeutics for Cancer provisional patent application entitled, “METHODS FOR INDUCING AND ENHANCING ANTI-CANCER IMMUNE RESPONSES USING NOVEL MOLECULAR CONSTRUCTS”, filed on April 23, 2020.
  4. Novel Therapeutics for Cancer provisional patent application entitled, “MULTI-VALENT IMMUNOSTIMULATORS FOR INFECTIOUS DISEASES, AUTOIMMUNE DISEASES, ALLERGIC DISEASES AND CANCER”, filed on May 15, 2020.
  5. Novel Treatment and Diagnosis of Coronavirus Disease patent application entitled, “MULTI-VALENT DECOY RECEPTORS FOR DIAGNOSIS AND/OR TREATMENT OF CORONAVIRUS INFECTION”, filed on June 22, 2020.

 

To the knowledge of the Company’s management, there are no contested proceedings or third-party claims over any of our patent applications. Our success depends upon our ability to protect our technologies through intellectual property agreements including patents, trademarks, know-how, and confidentiality agreements. However, there can be no assurance that the above-mentioned patent applications will be approved by the appropriate agencies.

 

All of the technology for which patents are currently sought is owned by the Company. Our patents are entirely owned or exclusively licensed by the Company.

 

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Competition

 

Cancer immunotherapy has become a significant growth area for the biopharmaceutical industry, attracting large pharmaceutical companies as well as small niche players. Generally, our principal competitors in the cancer immunotherapy market comprise both companies with currently approved products for various indications, such as manufacturers of approved bispecific antibodies, CAR-T cells, and checkpoint inhibitors, as well as companies currently engaged in cancer immunotherapy clinical development. The large and medium-size players who have successfully obtained approval for cancer immunotherapy products include Bristol-Myers Squib Company, Merck & Co., Inc., Genentech, Inc. (a subsidiary of Roche Holding AG), AstraZeneca PLC, Celgene Corporation, Johnson & Johnson/Janssen Pharmaceuticals, Amgen, Novartis, Acerta Pharmaceuticals (a subsidiary of AstraZeneca), Juno Therapeutics, Inc. (a subsidiary of Celgene), Kite Pharma, Inc., a wholly-owned subsidiary of Gilead Sciences, Inc. and Pfizer, Inc./EMD Serono, Inc. Most of these companies, either alone or together with their collaborative partners, have substantially greater financial resources than we do.

 

Companies developing novel products with similar indications to those we are pursuing are expected to influence our ability to penetrate and maintain market share. For patients with early stage breast cancer, adjuvant therapy is often given to prevent recurrence and increase the chance of long-term DFS. Adjuvant therapy for breast cancer can include chemotherapy, hormonal therapy, radiation therapy, or combinations thereof. In addition, the HER2 targeted drug trastuzumab (HERCEPTIN) - alone or in combination with pertuzumab (PERJETA), both manufactured and marketed by Roche/Genentech may be given to patients with tumors with high expression of HER2 (IHC 3+), as well as other novel targets such as MUC1, which may be useful in treating breast cancer. In addition, the FDA recently approved the first ever immunotherapy regimen for breast cancer to the Roche/Genentech PD-L1 checkpoint inhibitor atezolizumab (TECENTRIQ), combined with Celgene’s nab-paclitaxel (ABRAXANE) for TNBC that cannot be removed with surgery and is locally advanced or metastatic.

 

There are a number of cancer vaccines in development for breast cancer, including but not limited toTPIV200 (Marker Therapeutics, Inc.), AE-37 (Antigen Express), and Stimuvax (Merck KgA). While these development candidates are aimed at a number of different targets, and AE-37 has published data in the HER2 breast cancer patient population, there is no guarantee that any of these compounds will not in the future be indicated for treatment of low-to-intermediate HER2 breast cancer patients and become directly competitive with NPS.

 

Many of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than we do, and also have greater experience in obtaining FDA and other regulatory approvals of treatments and commercializing those treatments. Accordingly, our competitors may be more successful than us in obtaining approval for cancer immunotherapy products and achieving widespread market acceptance. Our competitors’ treatments may be more effectively marketed and sold than any products we may commercialize, thus causing limited market share before we can recover the expenses of developing and commercializing of our cancer immunotherapy product candidate.

 

Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These activities may lead to consolidated efforts that allow for more rapid development of cancer immunotherapy product candidates.

 

These competitors also compete with us in recruiting and retaining qualified scientific and management personnel, the ability to work with specific clinical contract organizations due to conflict of interest, and also the conduct of trials in the ability to recruit clinical trial sites and subjects for our clinical trials.

 

We expect any products that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, price and the availability of reimbursement from government and other third-party payors. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are viewed as safer, more convenient or less expensive than any products that we may develop. Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for our current product candidates or any other future product candidate, which could result in our competitors establishing a strong market position before we are able to enter the market.

 

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Employees

 

As of July 31, 2020, we had five full-time employees and one part-time employee, located in Berkeley, CA; Los Angeles, CA; Havertown, PA and Tel Aviv, Israel.

 

For each of the years ended July 31, 2017, 2018, 2019 and 2020, the average number of employees, including executives, has been four, of whom two were executive management and two were engaged in research and development. Of these four employees, three were located in California and one in Pennsylvania.

 

Research and Development Activities and Costs

 

For information regarding our clinical studies, please see above under the caption “– Clinical Studies in Process.”

 

For the years ended July 31, 2020, 2019, 2018, 2017 and 2016, we incurred $2,980,144, $4,917,287, $3,112,579, $2,125,941, and $944,942, respectively, of net research and development expense.  

 

Manufacturing

 

We do not own or operate manufacturing facilities for the production of our product candidates, nor do we have plans to develop our own manufacturing operations in the foreseeable future. We currently depend on third-party contract manufacturers for all of our required raw materials, active pharmaceutical ingredients, and finished product candidate for our clinical trials. We currently employ internal resources and third-party consultants to manage our manufacturing contractors.

 

Bria-IMT™ is currently manufactured under cGMP pursuant to agreements with the University of California, Davis Health System and with KBI Biopharma, Inc. (“KBI”), which is located in The Woodlands, Texas.

 

On June 11, 2015, the Company entered into an Agreement for Services with The Regents of the University of California, acting for and on behalf of its University of California, Davis Health System (“UC Davis”), pursuant to which UC Davis manufactures Bria-IMT (previously known as BriaVax) at its GMP facility. The Company pays UC Davis certain hourly rates depending on the specific services provided by UC Davis in connection with its manufacturing of Bria-IMT. Either Party may terminate this Agreement without cause by giving thirty (30) calendar days written notice to the other. To effect termination in the event of a material breach of this Agreement, the aggrieved party must provide written notice of the breach to the offending party and allow the offending party ten (10) business days to cure the breach. If the offending party does not cure the breach within ten (10) business days, the Agreement will immediately and automatically terminate on the eleventh (11th) day. This Agreement shall be subject to immediate termination in the event that any Party is excluded from participation in any federal healthcare or procurement program. Termination or expiration of this Agreement shall not affect any rights or obligations of the Parties that accrued prior to the date of termination. BriaCell shall pay UC Davis for all Services rendered and obligations incurred under the Agreement that cannot reasonably be terminated immediately upon notice of termination up to the date of termination of this Agreement, regardless of the reason for termination.

 

Pursuant to the Company’s Masters Services Agreement with KBI, dated March 17, 2017, KBI has conducted developmental studies to derive and optimize a cryopreserved formulation of Bria-IMT (previously known as BriaVax) as a research working cell bank (RCB) of final drug product doses suitable for cold chain shipment (the “KBI Services”). The Company pays for the cost of materials, consumables, and third party services, plus an additional 5% fee to compensate KBI for the cost of purchasing, material handling, inventory and administration and management of third party services necessary for KBI Biopharma to perform the KBI Services. The Masters Services Agreement with KBI terminates on March 17, 2022. BriaCell may terminate this Agreement or a Proposal prior to completion of the Proposal by providing sixty (60) days written notice to KBI Biopharma. In the event that this Agreement or a Proposal is terminated for any reason other than (i) by Client for KBI Biopharma’s material breach or (ii) by Client, Client shall pay KBI Biopharma upon receipt of invoice all of its costs for Services performed and expenses incurred or irrevocably obligated related to the Proposal and wind down of activities, plus, as liquidated damages and not as a penalty, an amount equal to the greater of (a) twenty percent (20%) of the cost of the Services not yet performed as of the effective date of termination for any Proposal terminated; or (b) the amounts due for cancellation or postponement of any manufacturing runs scheduled within 180 days of the termination. In the event of a material breach of this Agreement by a Party that is not cured within thirty (30) days of written notice of such breach by the non-breaching Party, the non-breaching Party may terminate this Agreement or a Proposal immediately upon written notice. Upon such termination, KBI Biopharma will promptly scale down the affected portion of the Proposal and use its reasonable commercial efforts to avoid (or minimize, where non-cancellable) additional expenses. It is understood between the Parties that KBI Biopharma will incur substantial costs for reservations of resources and planning in order to undertake the provision of Services. Therefore, in the event of termination by KBI Biopharma, Client shall pay KBI Biopharma upon receipt of invoice all of its costs incurred or irrevocably obligated related to the Proposal and wind down of activities, plus, as liquidated damages and not as a penalty, an amount equal to the greater of (a) fifty percent (50%) of the cost of the Services not yet performed as of the effective date of termination for any Proposal terminated; or (b) the amounts due for cancellation or postponement of any manufacturing runs scheduled within 180 days of the termination. In the event of termination by Client, Client’s sole remedy shall be a reduction in the total contract price for the Services in an amount equal to the difference between: (i) the total contract price for the Proposal; and, (ii) the price of the Services properly performed. This Agreement may also be terminated upon written notice by a Party in the event: (i) the other Party voluntarily enters into bankruptcy proceedings; (ii) the other Party makes an assignment for the benefit of creditors; (iii) a petition is filed against the other Party under a bankruptcy law, a corporate reorganization law, or any other law for relief of debtors or similar law analogous in purpose or effect, which petition is not stayed or dismissed within thirty (30) days of filing thereof; or (iv) the other Party enters into liquidation or dissolution proceedings or a receiver is appointed with respect to any assets of the other Party, which appointment is not vacated within one hundred and twenty (120) days.

 

Sales and Marketing

 

We have not yet defined our sales, marketing or product distribution strategy for our product candidates or any future product candidates. Our future commercial strategy may include the use of strategic partners, distributors, a contract sale force, or the establishment of our own commercial and specialty sales force, as well as similar strategies for regions and territories outside the United States. We plan to further evaluate these alternatives as we approach approval for the use of our product candidates for one or more indications.

 

Property, Plant and Equipment

 

We do not own any real property. Our corporate offices in Canada are located at Suite 300, Bellevue Centre, 235-15th Street, West Vancouver, BC V7T 2XI. Our corporate and research offices in the United States are located at 820 Heinz Avenue, Berkeley, California, 94710.

 

We consider our current office space sufficient to meet our anticipated needs for the foreseeable future and suitable for the conduct of our business.

 

Government Regulation

 

The FDA and other regulatory authorities at federal, state, and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring, and post-approval reporting of biologics such as those we are developing. Along with third-party contractors, we will be required to navigate the various preclinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval or licensure of its current or future product candidates. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources. A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved label.

 

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The process required by the FDA before biologic product candidates may be marketed in the United States generally involves the following:

 

completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s current Good Laboratory Practices, or GLP, regulations;
   
submission to the FDA of an Investigational New Drug Application (IND), which must become effective before clinical trials may begin and must be updated annually or when significant changes are made;
   
approval by an independent Institutional Review Board, or IRB, or ethics committee at each clinical site before the trial is begun;
   
performance of adequate and well-controlled human clinical trials to establish the safety, purity and potency of the proposed biologic product candidate for its intended purpose;
   
preparation of and submission to the FDA of a Biologics License Application (BLA), after completion of all pivotal clinical trials;
   
satisfactory completion of an FDA Advisory Committee review, if applicable;
   
a determination by the FDA within 60 days of its receipt of a BLA to file the application for review;
   
satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with current Good Manufacturing Practices, or cGMP, and to assure that the facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity and potency, and of selected clinical investigations to assess compliance with current Good Clinical Practices, or GCP; and
   
FDA review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the United States, which must be updated annually when significant changes are made.

 

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The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our current or future product candidates will be granted on a timely basis, if at all. Prior to beginning the first clinical trial with a product candidate, we must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an investigational new drug to humans. The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical studies. The IND also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product; chemistry, manufacturing, and controls information; and any available human data or literature to support the use of the investigational product. An IND must become effective before human clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.

 

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCP, which include the requirement that all research subjects provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments. Furthermore, an IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site and must monitor the clinical trial until completed. Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also include oversight by a Data & Safety Monitoring Board (DSMB) organized by the clinical trial sponsor, which provides authorization for whether or not a clinical trial may move forward at designated check points based on access to certain data from the clinical trial and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy. There are also requirements governing the reporting of ongoing clinical studies and clinical trial results to public registries.

 

For purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap.

 

Phase 1-The investigational product is initially introduced into healthy human subjects or patients with the target disease or condition. These studies are designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
   
Phase 2-The investigational product is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials. In some cases, FDA will grant preliminary marketing authorization for drugs treating areas of high unmet medical need based on Phase 2 clinical trials. In this case, they will also require confirmatory Phase 3 evaluation post-marketing. BriaCell is evaluating Bria-IMT in patients with breast cancer who have failed at least two prior lines of therapy. In this population there is no approved therapy. Therefore, the development plan for Bria-IMT is an area of high unmet medical need. It is anticipated that BriaCell will not need to complete Phase 3 clinical trials prior to submitting the marketing application for Bria-IMT in patients with advanced breast cancer who have failed at least two prior lines of therapy. In this case a confirmatory Phase 3 evaluation post-marketing will be required. It is anticipated that this would consist of a randomized, controlled clinical trial of Bria-IMT in combination with immune checkpoint inhibitors compared with best available therapy. However, this design is subject to negotiation with the FDA.

 

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Phase 3-The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.
   
Phase 4-In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved to gain more information about the product. These so-called Phase 4 studies may be made a condition to approval of the BLA.

 

Phase 1, Phase 2 and Phase 3 testing may not be completed successfully within a specified period, if at all, and there can be no assurance that the data collected will support FDA approval or licensure of the product. Concurrent with clinical trials, companies may complete additional animal studies and develop additional information about the biological characteristics of the product candidate and must finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, must develop methods for testing the identity, strength, quality and purity of the final product, or for biologics, the safety, purity and potency. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

 

BLA Submission and Review by the FDA

 

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or more indications. The BLA must include all relevant data available from pertinent preclinical and clinical studies, including negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls, and proposed labeling, among other things. Data can come from company-sponsored clinical studies intended to test the safety and effectiveness of a use of the product, or from a number of alternative sources, including studies initiated by investigators. The submission of a BLA requires payment of a substantial user fee to FDA, and the sponsor of an approved BLA is also subject to annual product and establishment user fees. These fees are typically increased annually. A waiver of user fees may be obtained under certain limited circumstances.

 

Once a BLA has been submitted, the FDA’s goal is to review the application within ten months after it accepts the application for filing, or, if the application relates to an unmet medical need in a serious or life-threatening indication, six months after the FDA accepts the application for filing. The review process is often significantly extended by FDA requests for additional information or clarification. The FDA reviews a BLA to determine, among other things, whether a product is safe, pure and potent and the facility in which it is manufactured, processed, packed, or held meets standards designed to assure the product’s continued safety, purity and potency. The FDA may convene an advisory committee to provide clinical insight on application review questions. Before approving a BLA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

 

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The testing and approval process requires substantial time, effort and financial resources, and each may take several years to complete. The FDA may not grant approval on a timely basis, or at all, and we may encounter difficulties or unanticipated costs in its efforts to secure necessary governmental approvals, which could delay or preclude us from marketing its products. After the FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced, the FDA may issue an approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete and the application is not ready for approval. A Complete Response Letter may request additional information or clarification. The FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.

 

If regulatory approval of a product is granted, such approval may entail limitations on the indicated uses for which such product may be marketed. For example, the FDA may approve the BLA with a Risk Evaluation and Mitigation Strategy, or REMS, plan to mitigate risks, which could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing regulatory standards is not maintained or if problems occur after the product reaches the marketplace. The FDA may require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization and may limit further marketing of the product based on the results of these post-marketing studies. In addition, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our products under development.

 

A sponsor may seek approval of its product candidate under programs designed to accelerate FDA’s review and approval of new drugs and biological products that meet certain criteria. Specifically, new drugs and biological products are eligible for Fast Track designation if they are intended to treat a serious or life-threatening condition and demonstrate the potential to address unmet medical needs for the condition. For a product candidate with Fast Track designation, the FDA may consider sections of the BLA for review on a rolling basis before the complete application is submitted if relevant criteria are met. A Fast Track designated product candidate may also qualify for priority review, under which the FDA sets the target date for FDA action on the BLA at six months after the FDA accepts the application for filing. Priority review is granted when there is evidence that the proposed product would be a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition. If criteria are not met for priority review, the application is subject to the standard FDA review period of 10 months after FDA accepts the application for filing. Priority review designation does not change the scientific/medical standard for approval or the quality of evidence necessary to support approval.

 

Under the Accelerated Approval program, the FDA may approve a BLA on the basis of either a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. Post-marketing studies or completion of ongoing studies after marketing approval are generally required to verify the biologic’s clinical benefit in relationship to the surrogate endpoint or ultimate outcome in relationship to the clinical benefit.

 

In addition, a sponsor may seek FDA designation of its product candidate as a Breakthrough Therapy, if the product candidate is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. If the FDA designates a breakthrough therapy, it may take actions appropriate to expedite the development and review of the application. Breakthrough designation also allows the sponsor to file sections of the BLA for review on a rolling basis.

 

Fast Track, Priority Review and Breakthrough Therapy designations do not change the standards for approval but may expedite the development or approval process.

 

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Orphan Drugs

 

Under the Orphan Drug Act, the FDA may grant Orphan Drug Product Designation to a drug or biologic intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000 individuals in the United States, or a patient population greater than 200,000 individuals in the United States and when there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States will be recovered from sales in the United States for that drug or biologic. Orphan Drug Product Designation must be requested before submitting a BLA. After the FDA grants Orphan Drug Product Designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA.

 

If a product that has Orphan Drug Product Designation subsequently receives the first FDA approval for a particular active ingredient for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a full BLA, to market the same biologic for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. Orphan drug exclusivity does not prevent the FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition. Among the other benefits of Orphan Drug Product Designation are tax credits for certain research and a waiver of the BLA application user fee.

 

A drug with Orphan Drug Product Designation may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received Orphan Drug Product Designation. In addition, orphan drug exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

 

Other Healthcare Laws and Compliance Requirements

 

Our sales, promotion, medical education and other activities following product approval will be subject to regulation by numerous regulatory and law enforcement authorities in the United States in addition to FDA, including potentially the Federal Trade Commission, the Department of Justice, the Centers for Medicare and Medicaid Services, other divisions of the Department of Health and Human Services and state and local governments. Our promotional and scientific/educational programs must comply with the federal Anti-Kickback Statute, the Foreign Corrupt Practices Act, the False Claims Act, or FCA, the Veterans Health Care Act, physician payment transparency laws, privacy laws, security laws, and additional state laws similar to the foregoing.

 

The federal Anti-Kickback Statute prohibits, among other things, the offer, receipt, or payment of remuneration in exchange for or to induce the referral of patients or the use of products or services that would be paid for in whole or part by Medicare, Medicaid or other federal health care programs. Remuneration has been broadly defined to include anything of value, including cash, improper discounts, and free or reduced price items and services. The government has enforced the Anti-Kickback Statute to reach large settlements with healthcare companies based on sham research or consulting and other financial arrangements with physicians. Further, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA. Many states have similar laws that apply to their state health care programs as well as private payors.

 

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The FCA, imposes liability on persons who, among other things, present or cause to be presented false or fraudulent claims for payment by a federal health care program. The FCA has been used to prosecute persons submitting claims for payment that are inaccurate or fraudulent, that are for services not provided as claimed, or for services that are not medically necessary. Actions under the FCA may be brought by the Attorney General or as a qui tam action by a private individual in the name of the government. Violations of the FCA can result in significant monetary penalties and treble damages. The federal government is using the FCA, and the accompanying threat of significant liability, in its investigation and prosecution of pharmaceutical and biotechnology companies throughout the country, for example, in connection with the promotion of products for unapproved uses and other sales and marketing practices. The government has obtained multi-million and multibillion dollar settlements under the FCA in addition to individual criminal convictions under applicable criminal statutes. In addition, companies have been forced to implement extensive corrective action plans, and have often become subject to consent decrees or corporate integrity agreements, restricting the manner in which they conduct their business. The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, also created federal criminal statutes that prohibit, among other things, knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Given the significant size of actual and potential settlements, it is expected that the government will continue to devote substantial resources to investigating healthcare providers’ and manufacturers’ compliance with applicable fraud and abuse laws.

 

In addition, there has been a recent trend of increased federal and state regulation of payments made to physicians and other healthcare providers. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the Affordable Care Act, among other things, imposed new reporting requirements on drug manufacturers for payments or other transfers of value made by them to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members. Failure to submit required information may result in civil monetary penalties. Certain states also mandate implementation of commercial compliance programs, impose restrictions on drug manufacturer marketing practices and/or require the tracking and reporting of gifts, compensation and other remuneration to physicians and other healthcare professionals.

 

We may also be subject to data privacy and security regulation by both the federal government and the states in which it conducts its business. HIPAA, as amended by the Health Information Technology and Clinical Health Act, or HITECH, and their respective implementing regulations, imposes specified requirements relating to the privacy, security and transmission of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates,” defined as independent contractors or agents of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service for or on behalf of a covered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions. In addition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect.

 

If our operations are found to be in violation of any of such laws or any other governmental regulations that apply to it, we may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations, exclusion from participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability to operate our business and our financial results. Also, the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws generally prohibit companies and their intermediaries from making improper payments to foreign officials for the purpose of obtaining or retaining business. We cannot assure you that our internal control policies and procedures will protect us from reckless or negligent acts committed by our employees, future distributors, partners, collaborators or agents. Violations of these laws, or allegations of such violations, could result in fines, penalties or prosecution and have a negative impact on our business, results of operations and reputation.

 

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Coverage and Reimbursement

 

Sales of pharmaceutical products depend significantly on the availability of third-party coverage and reimbursement. Third-party payors include government health administrative authorities, managed care providers, private health insurers and other organizations. Although we currently believe that third-party payors will provide coverage and reimbursement for our product candidates, if approved, these third-party payors are increasingly challenging the price and examining the cost-effectiveness of medical products and services. In addition, significant uncertainty exists as to the reimbursement status of newly approved healthcare products. We may need to conduct expensive clinical studies to demonstrate the comparative cost-effectiveness of our product candidates. Seeking coverage and reimbursement from third-party payors can be time consuming and expensive. Moreover, a payor’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Reimbursement may not be available or sufficient to allow us to sell our products on a competitive and profitable basis.

 

Foreign Regulation

 

In addition to regulations in the United States, we are and will be subject, either directly or through our distribution partners, to a variety of regulations in other jurisdictions governing, among other things, clinical trials and commercial sales and distribution of our products, if approved.

 

Whether or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in non-U.S. countries prior to the commencement of clinical trials or marketing of the product in those countries. Certain countries outside of the United States have processes that require the submission of a clinical trial application much like an IND prior to the commencement of human clinical trials. In Europe, for example, a clinical trial application, or CTA, must be submitted to the competent national health authority and to independent ethics committees in each country in which a company plans to conduct clinical trials. Once the CTA is approved in accordance with a country’s requirements, clinical trials may proceed in that country.

 

The requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country, even though there is already some degree of legal harmonization in the European Union member states resulting from the national implementation of underlying E.U. legislation. In all cases, the clinical trials are conducted in accordance with GCP and other applicable regulatory requirements.

 

To obtain regulatory approval of a new drug or medicinal product in the European Union, a sponsor must obtain approval of a marketing authorization application. The way in which a medicinal product can be approved in the European Union depends on the nature of the medicinal product.

 

The centralized procedure results in a single marketing authorization granted by the European Commission that is valid across the European Union, as well as in Iceland, Liechtenstein and Norway. The centralized procedure is compulsory for human drugs that are: (i) derived from biotechnology processes, such as genetic engineering, (ii) contain a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions and viral diseases, (iii) officially designated as “orphan drugs” and (iv) advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines. The centralized procedure may at the request of the applicant also be used for human drugs which do not fall within the above mentioned categories if the human drug (a) contains a new active substance which was not authorized in the European Community; or (b) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorization in the centralized procedure is in the interests of patients or animal health at the European Community level.

 

Under the centralized procedure in the European Union, the maximum timeframe for the evaluation of a marketing authorization application by the EMA is 210 days (excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the Committee for Medicinal Products for Human Use, or CHMP), with adoption of the actual marketing authorization by the European Commission thereafter. Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of a major public health interest from the point of view of therapeutic innovation, defined by three cumulative criteria: the seriousness of the disease to be treated; the absence of an appropriate alternative therapeutic approach, and anticipation of exceptional high therapeutic benefit. In this circumstance, EMA ensures that the evaluation for the opinion of the CHMP is completed within 150 days and the opinion issued thereafter.

 

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The mutual recognition procedure, or MRP, for the approval of human drugs is an alternative approach to facilitate individual national marketing authorizations within the European Union. The MRP may be applied for all human drugs for which the centralized procedure is not obligatory. The MRP is applicable to the majority of conventional medicinal products, and is based on the principle of recognition of an already existing national marketing authorization by one or more member states.

 

The characteristic of the MRP is that the procedure builds on an already existing marketing authorization in a member state of the E.U. that is used as reference in order to obtain marketing authorizations in other E.U. member states. In the MRP, a marketing authorization for a drug already exists in one or more member states of the E.U. and subsequently marketing authorization applications are made in other European Union member states by referring to the initial marketing authorization. The member state in which the marketing authorization was first granted will then act as the reference member state. The member states where the marketing authorization is subsequently applied for act as concerned member states.

 

The MRP is based on the principle of the mutual recognition by European Union member states of their respective national marketing authorizations. Based on a marketing authorization in the reference member state, the applicant may apply for marketing authorizations in other member states. In such case, the reference member state shall update its existing assessment report about the drug in 90 days. After the assessment is completed, copies of the report are sent to all member states, together with the approved summary of product characteristics, labeling and package leaflet. The concerned member states then have 90 days to recognize the decision of the reference member state and the summary of product characteristics, labeling and package leaflet. National marketing authorizations shall be granted within 30 days after acknowledgement of the agreement.

 

Should any Member State refuse to recognize the marketing authorization by the reference member state, on the grounds of potential serious risk to public health, the issue will be referred to a coordination group. Within a timeframe of 60 days, member states shall, within the coordination group, make all efforts to reach a consensus. If this fails, the procedure is submitted to an EMA scientific committee for arbitration. The opinion of this EMA Committee is then forwarded to the Commission, for the start of the decision-making process. As in the centralized procedure, this process entails consulting various European Commission Directorates General and the Standing Committee on Human Medicinal Products or Veterinary Medicinal Products, as appropriate.

 

For other countries outside of the European Union, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, again, the clinical trials are conducted in accordance with GCP and the other applicable regulatory requirements.

 

If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension of clinical trials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

 

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WHERE YOU CAN FIND ADDITIONAL INFORMATION

 

We have filed with the SEC a registration statement on Form F-1 covering the securities in this offering. This prospectus, which forms part of the registration statement, does not contain all of the information set forth in the registration statement and the exhibits to the registration statement. Some items are omitted in accordance with the rules and regulations of the SEC. For further information regarding both our Company and the securities in this offering, we refer you to the registration statement and the exhibits to the registration statement filed as part of the registration statement. The SEC maintains an internet site at www.sec.gov, from which you can electronically access the registration statement, including the exhibits to the registration statement. We also maintain a website at http://www.briacell.com. You may access these materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. Information contained on our website is not a part of this prospectus and the inclusion of our website address in this prospectus is an inactive textual reference only.

 

LEGAL PROCEEDINGS

 

We are not a party to existing or pending legal proceedings against us, and we have no knowledge of any threatened litigation, nor are we involved as a plaintiff in any proceeding or pending litigation. There are no proceedings in which any of our directors, officers or any of their respective affiliates, or any beneficial shareholder, is an adverse party or has a material interest adverse to our interest.

 

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DIRECTORS, EXECUTIVE OFFICERS AND SIGNIFICANT EMPLOYEES

 

Our directors hold office until the next annual general meeting of the shareholders or until their successors are elected and qualified. Our officers are appointed by our Board and hold office until the earlier of their death, retirement, resignation, or removal. Unless otherwise stated, the address of each director and officer is c/o BriaCell Therapeutics Corp., Suite 300 - Bellevue Centre, 235 - 15th Street, West Vancouver, BC V7T 2X1.

 

Our officers, directors and significant employees and their ages and positions are as follows:

 

Name   Age   Position(s)
William V. Williams, M.D.   65   President, Chief Executive Officer and Director
Gadi Levin   47   Chief Financial Officer and Secretary
Jamieson Bondarenko   36   Chairman of the Board
Vaughn C. Embro-Pantalony   63   Director
Rebecca Taub, M.D.   68   Director
Charles Wiseman, M.D.   75   Director

Martin Schmieg

  58   Director

 

William V. Williams, MD, President, Chief Executive Officer and Director, is a seasoned biopharmaceutical executive with over 35 years of industry and academic expertise, including significant clinical management in multinational pharmaceutical companies. Dr. Williams has served as President, Chief Executive Officer and Director of the Company since November 1, 2016. Dr. Williams served as Vice President of Exploratory Development at Incyte Corporation from March 2005 through November 2016. There he facilitated entry of over 20 compounds into the clinic, including ruxolitinib (Jakafi), baricitinib (Olumiant), and epacadostat. Dr. Williams held several positions at GlaxoSmithKline Pharmaceuticals, including Head of Experimental Medicine and Vice President of Clinical Pharmacology from December 2000 through March 2002, Director and Head of Clinical Pharmacology, Oncology, Musculoskeletal and Inflammation from March 2002 through December 2004 and Director and Head of Clinical Pharmacology, Musculoskeletal, Inflammation, Gastrointestinal and Urology from December 2004 through March 2005. He has also served as Assistant Professor of Medicine and the Director of Rheumatology Research at the University of Pennsylvania from July 1991 through January 1998. Dr. Williams earned is BSc in Chemistry and Biotechnology from Massachusetts Institute of Technology and Medical Doctorate from Tufts University School of Medicine.

 

Gadi Levin, CA, MBA, Chief Financial Officer and Secretary, was appointed Chief Financial Officer and Secretary of the Company on February 1, 2016. Mr. Levin has also served as Chief Financial Officer and Director of Vaxil Bio Ltd since March 1, 2016 Mr. Levin has also serves as the Finance Director of Eco (Atlantic) Oil & Gas Ltd. since December 1, 2016. Mr. Levin has over 15 years of experience working with public US, Canadian and multi-jurisdictional public companies. Previously, Mr. Levin served as Chief Financial Officer of DarioHeath Corp from November 2013 through January 2015. Mr. Levin also served as the Vice President of Finance and Chief Financial Officer for two Israeli investment firms specializing in private equity, hedge funds and real estate. Mr. Levin began his CPA career at the accounting firm Arthur Andersen, where he worked for nine years, specializing in U.S. listed companies involved in IPOs. Mr. Levin has a Bachelor of Commerce degree in Accounting and Information Systems from the University of the Cape Town, South Africa, and a post graduate diploma in Accounting from the University of South Africa. He received his Chartered Accountant designation in South Africa and has an MBA from Bar Ilan University in Israel.

 

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Jamieson Bondarenko, CFA, CMT, Chairman of the Board, was appointed as a Director of the Company on February 12, 2019 and elected as Chairman on April 24, 2019. Mr. Bondarenko provides strategic capital markets & corporate development advice to early-stage life sciences companies through his merchant capital company, JGRNT Capital Corp., a company he founded in November 2016. From December 2016 through October 2017, He served as Principal and Managing Director of the Equity Capital Markets group of Eight Capital. He also held several positions in the Capital Markets division of Dundee Securities Ltd., including Managing Director from July 2016 through December 2016, Director from October 2015 through July 2016, Vice President from December 2012 through October 2015 and Associate from February 2010 through December 2012.

 

Vaughn C. Embro-Pantalony, MBA, FCPA, FCMA, CDIR, ACC, Director, has been a Director of the Company since his appointment on March 18, 2019. In February 2018, he joined the Board of Directors of Soricimed Biopharma Inc., a private clinical-stage biopharma company developing targeted cancer therapies, and in August 2018 he was appointed Chairman of the Board of Soricimed and he continues to serve in this capacity. He is also a Director of Microbix Biosystems Inc., a public company and leading manufacturer of viral and bacterial antigens and reagents for the global diagnostics industry. He originally joined the Microbix Board in February 2007, and he also served as its President and Chief Executive Officer from November 2012 to July 2017. He is President of Stratpath Management Inc., consulting on strategy and governance to the life sciences sector. He has held other executive positions in life sciences with responsibility for finance, business development, strategic planning and information technology including Vice President, Finance, and Chief Financial Officer of Novopharm Limited from May 2003 through April 2006; Vice President, Information Technology, and Chief Information Officer of Bayer Inc. from July 1999 through April 2003; Vice President, Finance and Administration of Bayer Healthcare from October 1996 through June 1999; and Director, Finance and Administration and Chief Financial Officer of Zeneca Pharma Inc. from March 1995 through August 1996. He received his bachelor’s degree from Wilfrid Laurier University and his master of business administration degree from University of Windsor. He is a Fellow Chartered Professional Accountant and a Chartered Director (C. Dir.) and is Audit Committee Certified (A.C.C.) through the Directors College, McMaster University. We believe that Mr. Embro-Pantalony is qualified to serve as a member of our Board due to his extensive experience as a pharmaceutical and life sciences executive.

 

Rebecca Taub, MD, Director, has been a Director of the Company since her appointment on March 18, 2019. Dr. Taub currently serves as the President of Research and Development for Madrigal Pharmaceuticals, a clinical-stage biopharmaceutical company. She previously served as Vice President of Research and Development from July 2016 through her recent promotion to President of Research and Development on June 27, 2019. She has also served as Madrigal’s Chief Medical Officer since July 2016. Dr. Taub served as the CEO and a Director of Madrigal from September 2011 through Madrigal’s merger with Synta Pharmaceuticals Corp. in July 2016. Prior to joining Madrigal, Dr. Taub served as Senior Vice President, Research and Development of VIA Pharmaceuticals from 2008 to 2011 and as Vice President, Research, Metabolic Diseases at Hoffmann-LaRoche from 2004 to 2008. In those positions, Dr. Taub oversaw clinical development and drug discovery programs in cardiovascular and metabolic diseases including the conduct of a series of Phase I and II proof of conduct clinical trials. Dr. Taub led drug discovery including target identification, lead optimization and advancement of preclinical candidates into clinical development. From 2000 through 2003, Dr. Taub worked at Bristol-Myers Squibb Co. and DuPont Pharmaceutical Company, in a variety of positions, including Executive Director of CNS and metabolic diseases research. Before becoming a pharmaceutical executive, Dr. Taub was a tenured Professor of Genetics and Medicine at the University of Pennsylvania, and remains an adjunct professor. Dr. Taub is the author of more than 120 research articles. Before joining the faculty of the University of Pennsylvania, Dr. Taub served as an Assistant Professor at the Joslin Diabetes Center of Harvard Medical School, Harvard University and an associate investigator with the Howard Hughes Medical Institute. Dr. Taub received her M.D. from Yale University School of Medicine and B.A. from Yale College. We believe that Dr. Taub is qualified to serve as a member of our Board due to her extensive experience as a pharmaceutical executive heading up major development programs in non-alcoholic steatohepatitis, or NASH.

 

Charles Wiseman, MD, Director, is a Co-Founder of BriaCell Therapeutics Corp. and brings more than 40 years of academic and clinical experience. Dr. Wiseman has been a Director of the Company since November 25, 2014. He is the inventor for most of the Company’s intellectual property and actively participates in its ongoing technology development. During his career, Dr. Wiseman has managed numerous clinical development teams and programs, with a focus in oncology, tumor immunology, vaccine development, and genetics. Dr. Wiseman previously served as a Assistant Professor at The University of Texas MD Anderson Cancer Center and as Clinical Professor of Medicine at the Division of Medical Oncology at the Keck-USC School of Medicine. He previously served as Acting Chief of the Division of Oncology/Hematology at the White Memorial Medical Center from 1989 through 1991, as well as the principal investigator for immunotherapy treatment protocols at the St. Vincent Cancer Treatment Center and the Los Angeles Oncologic Institute from 1980 through 2006. Dr. Wiseman received his B.S. and MD at UCLA, where he also served as the President of the Student American Medical Association.

 

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Martin Schmieg, Director, rejoined the Company’s Board on November 24, 2020. Having served as a member of BriaCell’s Board from 2016 to March 2019, Mr. Schmieg is a “C” level executive with a diversified background in the global biotech, med-tech and pharmaceutical industries with 40 years of business experience. He currently serves as Co-Founder and CEO of ClearIt, LLC, a private company based in Massachusetts. As a hands-on leader, Mr. Schmieg’s early career focused on accounting and financial management responsibilities serving as Chief Financial Officer to privately held Cytometrics, Inc., Advanced Bionics Corporation and publicly traded Sirna Therapeutics, Inc. and Isolagen, Inc.

 

In 2006, Mr. Schmieg assumed the position of Chief Executive Office of Freedom-2, Inc., a venture start-up in novel dermatology applications, which was reverse merged into Nuvilex, Inc., now PharmaCyte, Inc.

 

Since 2010, Mr. Schmieg has been providing strategic advisory services to the life sciences industry including engagements with the following companies: NeoStem, Inc. (now Caladrius Biosciences, Inc.), Beckman Coulter Genomics, Calimmune, Inc., Cryoport, Inc., Sapientia Pharmaceuticals, Inc. and Rokk3r Labs, LLC. Martin holds a BS from LaSalle University, Philadelphia, PA and is a certified public accountant.

 

Since leaving BriaCell’s Board in 2019, Mr. Schmieg has been employed as General Manager and CEO of ClearIt, LLC, an emerging technology company which is developing the ERASER System for aesthetic and medical skin treatments.

 

No Family Relationships

 

There is no family relationship between any director, executive officer and significant employee.

 

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Foreign Private Issuer Status

 

The Nasdaq Rules include certain accommodations in the corporate governance requirements that allow foreign private issuers, such as us, to follow “home country” corporate governance practices in lieu of the otherwise applicable corporate governance standards of the Nasdaq. The application of such exceptions requires that we disclose any significant ways in which our corporate governance practices differ from the Nasdaq Rules that we do not follow. When our shares are listed on the Nasdaq, we intend to continue to follow Canadian corporate governance practices in lieu of the requirement under Rule 5620(c) of the Nasdaq Rules that a company’s articles of incorporation provide for a quorum for any meeting of the holders of the company’s common shares that is not less than 33 1/3% of the outstanding common shares of the company. Our articles of incorporation provide that a quorum of shareholders is constituted by the holders of at least 5% of the shares entitled to vote at the meeting, present in person or represented by proxy, and at least two persons entitled to vote at the meeting, present in person or represented by proxy. In addition, we do not intend to follow Rule 5635 of the Nasdaq Rules that requires that shareholder approval be required for the Company to issue securities in connection with certain events, such as the acquisition of shares or assets of another company, the establishment of or amendments to equity-based compensation plans for employees, rights issues at or below market price, certain private placements, directed issues at or above market price and issuance of convertible notes. Neither Canadian securities laws nor British Columbia corporate law require shareholder approval for such transactions, except where such transactions constitute a “related party transaction” or “business combination” under Canadian securities laws or where such transaction is structured in a way that requires shareholder approval under the BCBCA, or where the TSX Venture Exchange requires the shareholder approval for the establishment of or amendments to equity-based compensation plans, in which case, we intend to follow our home country requirements.

 

Corporate Governance

 

Except as stated above, we intend to comply with the rules generally applicable to U.S. domestic companies listed on the Nasdaq. We may in the future decide to use other foreign private issuer exemptions with respect to some of the other Nasdaq listing requirements. Following our home country governance practices, as opposed to the requirements that would otherwise apply to a company listed on the Nasdaq, may provide less protection than is accorded to investors under the Nasdaq Rules applicable to U.S. domestic issuers.

 

The Canadian securities regulatory authorities have issued corporate governance guidelines pursuant to National Policy 58-201—Corporate Governance Guidelines, or the Corporate Governance Guidelines, together with certain related disclosure requirements pursuant to NI 58-101. The Corporate Governance Guidelines are recommended as “best practices” for issuers to follow. We recognize that good corporate governance plays an important role in our overall success and in enhancing shareholder value and, accordingly, we have adopted, or in connection with the closing of this offering will adopt, certain corporate governance policies and practices which reflect our consideration of the recommended Corporate Governance Guidelines.

 

The disclosure set out below includes disclosure required by NI 58-101 describing our approach to corporate governance in relation to the Corporate Governance Guidelines.

 

Composition of our Board

 

Under our amended articles of incorporation that will be in place at the closing of this offering, our Board is to consist of three directors and up to that number which was last set by ordinary resolution of the shareholders. As of the closing of this offering, our Board will be comprised of six directors, and under the BCBCA, as a reporting issuer, we must have no fewer than three directors. Under the BCBCA, a director may be removed with or without cause by a resolution passed by at least two-thirds of the votes cast by shareholders present in person or by proxy at a meeting and who are entitled to vote. The directors are appointed at the annual general meeting of shareholders and the term of office for each of the directors will expire at the time of our next annual shareholders meeting. Our amended articles of incorporation will provide that, between annual general meetings of our shareholders, the directors may appoint one or more additional directors, but the number of additional directors may not at any time exceed one-third of the number of directors who held office at the expiration of the last meeting of our shareholders. Under the BCBCA, there is no minimum number of directors required to be resident Canadians as defined in the BCBCA.

 

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Director Term Limits and Other Mechanisms of Board Renewal

 

Our Board has not adopted director term limits or other automatic mechanisms of Board renewal. Rather than adopting formal term limits, mandatory age-related retirement policies and other mechanisms of Board renewal, the nominating and corporate governance committee of our Board will develop a skills and competencies matrix for our Board as a whole and for individual directors. The nominating and corporate governance committee will also conduct a process for the assessment of our board of directors, each committee and each director regarding his or her effectiveness and contribution, and will report evaluation results to our Board on a regular basis.

 

Director Independence

 

Under the Nasdaq Rules, independent directors must comprise a majority of a listed company’s board of directors within a specified period after the closing of this offering. For purposes of the Nasdaq Rules, an independent director means a person other than an executive officer or employee of the company who, in the opinion of the board of directors, has no relationship with the company that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. Under NI 58-101, a director is considered to be independent if he or she is independent within the meaning of Section 1.4 of National Instrument 52-110—Audit Committees. Section 1.4 of NI 52-110 generally provides that a director is independent if he or she has no direct or indirect relationship with the issuer which could, in the view of the issuer’s board of directors, be reasonably expected to interfere with the exercise of the director’s independent judgment.

 

Our Board has undertaken a review of the independence of each director. Based on information provided by each director concerning his or her background, employment and affiliations, our Board has determined that Mr. Embro-Pantalony, Dr. Taub and Mr. Schmieg representing three of the six members of our Board, are “independent” as that term is defined under the Nasdaq Rules and NI 58-101. In making this determination, our Board considered the current and prior relationships that each non-employee director has with our company and all other facts and circumstances our Board deemed relevant in determining their independence, including the beneficial ownership of our shares by each non-employee director. Dr. Williams is not independent by reason of the fact that he is our Chief Executive Officer.

 

Certain members of our Board are also members of the boards of other public companies. See “—Directors, Executive Officers and Significant Employees”. Our Board has not adopted a director interlock policy, but is keeping informed of other public directorships held by its members.

 

Mandate of the Board of Directors

 

Our Board is responsible for supervising the management of our business and affairs, including providing guidance and strategic oversight to management. Our Board will adopt a formal mandate that will include the following:

 

  appointing our Chief Executive Officer;

 

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  developing the corporate goals and objectives that our Chief Executive Officer is responsible for meeting and reviewing the performance of our Chief Executive Officer against such corporate goals and objectives;
     
  taking steps to satisfy itself as to the integrity of our Chief Executive Officer and other executive officers and that our Chief Executive Officer and other executive officers create a culture of integrity throughout the organization;
     
  reviewing and approving our code of conduct and reviewing and monitoring compliance with the code of conduct and our enterprise risk management processes;
     
  reviewing and approving management’s strategic and business plans and our financial objectives, plans and actions, including significant capital allocations and expenditures; and
     
  reviewing and approving material transactions not in the ordinary course of business.

 

Meetings of Independent Directors

 

Our Board will hold regularly-scheduled quarterly meetings as well as ad hoc meetings from time to time. The independent members of our Board will also meet, as required, without the non-independent directors and members of management before or after each regularly scheduled board meeting.

 

A director who has a material interest in a matter before our Board or any committee on which he or she serves is required to disclose such interest as soon as the director becomes aware of it. In situations where a director has a material interest in a matter to be considered by our Board or any committee on which he or she serves, such director may be required to absent himself or herself from the meeting while discussions and voting with respect to the matter are taking place. Directors will also be required to comply with the relevant provisions of the BCBCA regarding conflicts of interest.

 

Position Descriptions

 

Prior to the closing of this offering, our Board will adopt written terms of reference for the chairman which will set out his or her key responsibilities, including duties relating to determining the frequency, dates and locations of meetings and setting Board meeting agendas, chairing Board and shareholder meetings and carrying out any other or special assignments or any functions as may be requested by our Board or management, as appropriate.

 

Prior to the closing of this offering, our Board will also adopt written terms of reference for each of the committee chairs which will set out each of the committee chair’s key responsibilities, including duties relating to determining the frequency, dates and locations of meetings and setting committee meeting agendas, chairing committee meetings, reporting to our Board and carrying out any other special assignments or any functions as may be requested by our Board.

 

In addition, prior to the closing of this offering, our Board, in conjunction with our Chief Executive Officer, will develop and implement a written position description for the role of our Chief Executive Officer.

 

Orientation and Continuing Education

 

Following the closing of this offering, we will implement an orientation program for new directors under which a new director will meet separately with the chairman of our Board, members of the senior executive team and the secretary.

 

The nominating and corporate governance committee will be responsible for coordinating orientation and continuing director development programs relating to the committee’s mandate. The chairman of our Board will be responsible for overseeing director continuing education designed to maintain or enhance the skills and abilities of our directors and to ensure that their knowledge and understanding of our business remains current.

 

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Code of Conduct

 

The Board has not adopted a formal written Code of Business Conduct and Ethics. However, the small size of the Board and number of officers and employees allows the Board to monitor on an ongoing basis the activities of management and to ensure that the highest standard of ethical conduct is maintained. The Board views good corporate governance as an integral component to its success and to meet its responsibilities to shareholders. As the Company grows in size and scope, the Board anticipates that it will formulate and implement a formal Code of Business Conduct and Ethics.

 

Monitoring Compliance with the Code of Conduct

 

Our nominating and corporate governance committee will be responsible for reviewing and evaluating the code of conduct at least annually and will recommend any necessary or appropriate changes to our Board for consideration. The nominating and corporate governance committee will assist our Board with the monitoring of compliance with the code of conduct, and will be responsible for considering any waivers therefrom (other than waivers applicable to members of the nominating and corporate governance committee, which shall be considered by the audit committee, or waivers applicable to our directors or executive officers, which shall be subject to review by our Board as a whole).

 

Requirement for Directors and Officers to Disclose Interest in a Contract or Transaction

 

In accordance with the BCBCA, each director and officer must disclose the nature and extent of any interest that he or she has in a material contract or material transaction whether made or proposed with us, if the director or officer is a party to the contract or transaction, is a director or an officer or an individual acting in a similar capacity of a party to the contract or transaction, or has a material interest in a party to the contract or transaction. Subject to certain limited exceptions under the BCBCA, no director may vote on a resolution to approve a material contract or material transaction which is subject to such disclosure requirement.

 

As of the date hereof, except as otherwise disclosed in this prospectus, to the knowledge of the Board or the management of the Company, there are no material interests, whether direct or indirect, of any informed person of the Company, any proposed director of the Company, or any associate or affiliate of any informed person or proposed director, in any transaction since the commencement of the Company’s most recently completed financial year or in any proposed transaction which has materially affected or would materially affect the Company of any of its subsidiaries.

 

Benefits upon Termination of Employment

 

The service contracts with our directors do not provide for any benefits upon termination of employment, other than a “tail” directors and officers insurance policy.

 

Complaint Reporting

 

In order to foster a climate of openness and honesty in which any concern or complaint pertaining to a suspected violation of the law, our code of conduct or any of our policies, or any unethical or questionable act or behavior, our code of conduct will require that our employees promptly report the violation or suspected violation. In order to ensure that violations or suspected violations can be reported without fear of retaliation, harassment or an adverse employment consequence, we will adopt a whistleblowing policy which will contain procedures that are aimed to facilitate confidential, anonymous submissions of complaints by our directors, officers, employees and others.

 

Committees of the Board

 

We currently have an audit committee, a compensation committee and a nominating and corporate governance committee, with each committee having a written charter.

 

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Audit Committee

 

Our Audit Committee is currently comprised of Vaughn C. Embro-Pantalony, Martin Schmieg and Dr. Rebecca Taub, and chaired by Mr. Embro-Pantalony. Our Board has determined that each of Mr. Schmieg and Mr. Embro-Pantalony is financially literate and meets the independence requirements for directors, including the heightened independence standards for members of the audit committee under Rule 10A-3 under the Exchange Act and NI 52-110. Our Board has determined that Mr. Embro-Pantalony is “financially sophisticated” within the meaning of the Nasdaq Rules, “financially literate” within the meaning of NI 52-110, and a “financial expert” as defined by Rule 10A-3 under the Exchange Act. For a description of the education and experience of each member of the audit committee, see “—Directors, Executive Officers and Significant Employees”.

 

We have adopted an Audit Committee Charter setting forth the purpose, composition, authority and responsibility of the audit committee. The primary function of the audit committee is to assist the Board in fulfilling its financial oversight responsibilities by reviewing the financial reports and other financial information provided by the company to regulatory authorities and the Company’s shareholders, the Company’s systems of internal controls regarding finance and accounting and the Company auditing, accounting and financial reporting processes. Consistent with this function, the Committee will encourage continuous improvement of, and should foster adherence to, Company’s policies, procedures and practices at all levels. The Committee’s primary duties and responsibilities are to:

 

  Serve as an independent and objective party to monitor the Company’s financial reporting and internal control system and review Company’s financial statements;
  Review and appraise the performance of the Company’s external auditors; and
  Provide an open avenue of communication among the Company’s auditors, financial and senior management and the Board.

  

The Audit Committee shall meet at least annually, or more frequently as circumstances dictate. As part of its job to foster open communication, the Audit Committee will meet at least annually with the external auditors.

 

To fulfill its responsibilities and duties, the Audit Committee shall:

 

  Review and update the Audit Committee’s charter annually;
  Review the Company’s financial statements, Management Discussion & Analysis and any annual and interim earnings, press releases before the Company publicly discloses this information and any reports or other financial information (including quarterly financial statements), which are submitted to any governmental body, or to the public, including any certification, report, opinion, or review rendered by the external auditors;
  Review annually, the performance of the external auditors who shall be ultimately accountable to the Board and the Committee as representatives of the shareholders of the Company;
  Obtain annually, a formal written statement of external auditors setting forth all relationships between the extern auditors and the Company, consistent with Independence Standards Board Standard I;
  Review and discuss with the external auditors any disclosed relationships or services that may impact the objectivity and independence of the external auditors;
  Take, or recommend that the full Board take, appropriate action to oversee the independence of the external auditors;
  Recommend to the Board the selection and, where applicable, the replacement of the external auditors nominated annually for shareholder approval;
  Review and approve the Company’s hiring policies regarding partners, employees and former partners and employees of the present and former external auditors of the Company;
  Review and pre-approve all audit and audit-related services and the fees and other compensation related thereto;
  In consultation with the external auditors, review with management the integrity of the Company’s financial reporting process, both internal and external;
  Consider the external auditors’ judgments about the quality and appropriateness of the Company’s accounting principles as applied in its financial reporting;
  Consider and approve, if appropriate, changes to the Company’s auditing and accounting principles and practices as suggested by the external auditors and management;

 

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  Review significant judgments made by management in the preparation of the financial statements and the view of the external auditors as to appropriateness of such judgments;
  Following completion of the annual audit, review separately with management and the external auditors any significant difficulties encountered during the course of the audit, including any restrictions on the scope of work or access to required information;
  Review any significant disagreement among management and the external auditors in connection with the preparation of the financial statements;
  Review with the external auditors and management the extent to which changes and improvements in financial or accounting practices have been implemented;
  Review any complaints or concerns about any questionable accounting, internal accounting controls or auditing matters;
  Review certification process; and
  Review any related-party transactions.

 

Principal Accountant’s Fees

 

Aggregate fees billed by MNP LLP, our independent auditor, in the fiscal years ended July 31, 2020 and 2019 were approximately $163,199 and $90,490, respectively, as detailed below.

 

   Fees billed for the
fiscal year ended July 31
 
Service Retained  2020   2019 
Audit fees(1)  $ 55,000    $71,000 
Audit-related fees    3,220     8,250 
Tax fees(2)  $ 5,083    $5,000 
Interim reviews   $ 49,852    $ -  
All other fees(3)  $ 50,044    $6,240 
Total  $ 163,199    $90,490 

 

 

 

(1) Aggregate fees billed by the auditor (or accrued) for assurance and related services that are reasonably related to the performance of the audit or review of the Company’s financial statements.
   
(2) Aggregate fees billed by the auditor (or accrued) for professional services rendered for tax compliance, tax advice and tax planning.
   
(3) Aggregate fees billed by the auditor (or accrued) and not included above.

 

Compensation Committee

 

Compensation committees are not mandatory in Canada. However, National Policy 58-201 - Corporate Governance Guidelines recommends that a Board appoint a compensation committee composed entirely of independent directors with responsibilities for oversight of the compensation payable to senior executives. The members of the compensation committee are not required to be independent or to have any particular expertise.

 

Our compensation committee is comprised of Mr. Embro-Pantalony and Mr. Schmieg and will be chaired by Mr. Schmieg. The Compensation Committee is appointed by the Board to assist in promoting a culture of integrity throughout the Company, to assist the Board in setting director and senior executive compensation, and to develop and submit to the Board recommendations with respect to other employee benefits as the Compensation Committee sees fit. In the performance of its duties, the Compensation Committee is guided by the following principles:

 

  offering competitive compensation to attract, retain and motivate highly qualified executives in order for the Company to meet its goals; and

 

  acting in the interests of the Company and the shareholders by being fiscally responsible.

 

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The Board relies on the knowledge and experience of the members of the Compensation Committee to set appropriate levels of compensation for senior officers. Neither the Company nor the Compensation Committee currently has, or has had at any time since incorporation, any contractual arrangement with any executive compensation consultant who has a role in determining or recommending the amount or form of senior officer compensation.

 

When determining compensation payable, the Compensation Committee considers both external and internal data. External data includes general markets conditions and well as information regarding compensation paid to directors, CEOs and CFOs of companies of similar size and at a similar stage of development in the industry. Internal data includes annual reviews of the performance of the directors, CEO and CFO in light of the Company’s corporate objectives and considers other factors that may have impacted the Company’s success in achieving its objectives.

 

Nominating and Corporate Governance Committee

 

Nominating and Corporate Governance Committees are not mandatory in Canada. However, NP 58-201 recommends that a board appoint a corporate governance committee composed entirely of independent directors with responsibility for overseeing the process for nominating directors for election by shareholders. The members of the corporate governance committee are not required to be independent or to have any particular expertise.

 

The Nominating and Corporate Governance Committee is appointed by the Board to assist in fulfilling its corporate governance responsibilities under applicable laws. The Nominating and Corporate Governance Committee is responsible for, among other things, developing the Company’s approach to governance issues and establishing sound corporate governance practices that are in the interests of shareholders and that contribute to effective and efficient decision-making.

 

Our Nominating and Corporate Governance Committee is currently comprised of Mr. Embro-Pantalony and Dr. Taub and is chaired by Mr. Embro-Pantalony.

 

Exculpation, Insurance and Indemnification of Directors and Officers

 

Under the BCBCA, a company may indemnify: (i) a current or former director or officer of that company; (ii) a current or former director or officer of another corporation if, at the time such individual held such office, the corporation was an affiliate of the company, or if such individual held such office at the company’s request; or (iii) an individual who, at the request of the company, held, or holds, an equivalent position in another entity (an “indemnifiable person”) against all costs, charges and expenses, including an amount paid to settle an action or satisfy a judgment, reasonably incurred by him or her in respect of any civil, criminal, administrative or other legal proceeding or investigative action (whether current, threatened, pending or completed) in which he or she is involved because of that person’s position as an indemnifiable person, unless: (i) the individual did not act honestly and in good faith with a view to the best interests of such company or the other entity, as the case may be; or (ii) in the case of a proceeding other than a civil proceeding, the individual did not have reasonable grounds for believing that the individual’s conduct was lawful. A company cannot indemnify an indemnifiable person if it is prohibited from doing so under its articles or by applicable law. A company may pay, as they are incurred in advance of the final disposition of an eligible proceeding, the expenses actually and reasonably incurred by an indemnifiable person in respect of that proceeding only if the indemnifiable person has provided an undertaking that, if it is ultimately determined that the payment of expenses was prohibited, the indemnifiable person will repay any amounts advanced. Subject to the aforementioned prohibitions on indemnification, a company must, after the final disposition of an eligible proceeding, pay the expenses actually and reasonably incurred by an indemnifiable person in respect of such eligible proceeding if such indemnifiable person has not been reimbursed for such expenses, and was wholly successful, on the merits or otherwise, in the outcome of such eligible proceeding or was substantially successful on the merits in the outcome of such eligible proceeding. On application from an indemnifiable person, a court may make any order the court considers appropriate in respect of an eligible proceeding, including the indemnification of penalties imposed or expenses incurred in any such proceedings and the enforcement of an indemnification agreement. As permitted by the BCBCA, under Article 21.1, we are required to indemnify our directors and former directors (and such individual’s respective heirs and legal representatives) and permit us to indemnify any person to the extent permitted by the BCBCA.

 

The BCBCA provides certain protections under Part 5 – Management, Division 5 - Indemnification of Directors and Officers and Payment of Expenses, to our current and former directors and officers, as well as other eligible parties defined in Section 159 of the BCBCA (the “Eligible Parties”, each an “Eligible Party”). The Company will indemnify the Eligible Parties, to the fullest extent permitted by law and subject to certain limitations listed in Section 163 of the BCBCA, against any proceeding in which an Eligible Party or any of the heirs and personal or other legal representatives of the Eligible Party, by reason of the Eligible Party being or having been a director or officer of, or holding or having held a position equivalent to that of a director or officer of, the Company or an associated corporation (a) is or may be joined as a party, or (b) is or may be liable for or in respect of a judgment, penalty or fine in, or expenses related tom, the proceeding.

 

We maintain insurance policies relating to certain liabilities that our directors and officers may incur in such capacity.

 

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EXECUTIVE COMPENSATION

 

The following table provides a summary of compensation paid, directly or indirectly, for the year ended July 31, 2020 to the directors, officers and senior management:

 

Table of Compensation Excluding Compensation Securities
Name and position   Year     Salary, consulting fee, retainer or commission
($)
    Value of all other compensation
($)(1)
    Total compensation
($)
 
William V. Williams(2)
President, Chief Executive Officer, Director
  2020       283,440             -       283,440  
Gadi Levin(3)
Chief Financial Officer and Secretary
  2020       52,500       -       52,500  
Rahoul Sharan(4)
Former Director
  2020       22,500       -       22,500  
Martin Schmieg(6)
Director
  2020       -       -       -  
Charles Wiseman
Director
  2020       73,099       -       73,099  
Jamieson Bondarenko
Chairman of the Board
  2020       108,271       -       108,271  
Rebecca Taub
Director
  2020       43,516       -       43,516  
Vaughn C. Embro-Pantalony
Director
  2020       39,332       -       39,332  

 

(1) Options based awards calculated using the Black-Scholes Option Pricing Model.

 

(2) On November 1, 2016, Dr. William V. Williams was appointed as President and Chief Executive Officer of the Company.

 

(3) On February 11, 2016, Gadi Levin was appointed as Chief Financial Officer and Corporate Secretary of the Company.

 

(4) Mr. Sharan resigned from the Board effective March 18, 2019.

 

(5) Mr. Babaei resigned from the Board effective March 18, 2019.

 

(6) Mr. Schmieg resigned from the Board effective March 14, 2019 and rejoined the Board on November 24, 2020.

 

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Stock Options and Other Compensation Securities

 

The Company’s Stock Option Plan was previously approved by the shareholders at the Company’s annual and special meeting on November 25, 2014.

 

The following table provides a summary of all compensation securities granted or issued to each director, officer and senior management as of July 31, 2019.

 

Compensation Securities
Name and position  Type of compensation security   Number of compensation securities, number of underlying securities, and percentage of class   Expiry date   exercise price
($)
 
William V. Williams
President & Chief Executive
   Stock Options    2,500    March 1, 2021   $45.00 
Officer, Director               
Gadi Levin,
Chief Financial Officer and Secretary
   Stock Options    667    March 1, 2021   $45.00 
Charles Wiseman
Director
   Stock Options    1,667    March 1, 2021   $45.00 
Jamieson Bondarenko
Chairman of the Board of Directors
   Stock Options    6,667    March 15, 2021   $45.00 
Markus D. Lacher   Stock Options    333    March 1, 2021   $45.00 
Former Senior Director of Research and Development   Stock Options    1,667    November 4, 2020   $76.50 
Rebecca Taub
Director
   -    -    -    - 
Vaughn C. Embro-Pantalony
Director
   -    -    -    - 
Martin Schmieg
Director
                               

 

100
 

 

Oversight and Description of Compensation

 

Compensation of Directors

 

The Company provides a modest cash retainer to its non-executive directors. Executive directors do not receive any cash compensation in their capacity as directors. Long term incentives (stock options) are granted from time to time, based on an existing complement of long-term incentives, corporate performance and to be competitive with other companies of similar size and scope.

 

Compensation of Executive Officers

 

The Company’s Compensation Committee is responsible for, among other things, evaluating the performance of the Company’s executive officers, determining or making recommendations to the Board with respect to the compensation of the Company’s executive officers, making recommendations to the Board with respect to director compensation, incentive compensation plans and equity-based plans, making recommendations to the Board with respect to the compensation policy for the employees of the Company and ensuring that the Company is in compliance with all legal requirements with respect to compensation disclosure. In performing its duties, the Compensation Committee has the authority to engage such advisors, including executive compensation consultants, as it considers necessary.

 

Philosophy and Objectives

 

The compensation program for senior management of the Company is designed to ensure that the level and form of compensation achieves certain objectives, including:

 

  a) attracting and retaining talented and highly-qualified executives;

 

  b) motivating the short and long term performances of executives; and

 

  c) creating a corporate environment which aligns their interests with those of the shareholders.

  

The compensation program is designed to provide competitive levels of compensation. The Company recognizes the need to provide a total compensation package that will attract and retain qualified and experienced executives as well as align the compensation level of each executive to that executive’s level of responsibility. In general, the Company’s executive officers may receive compensation that is comprised of three components: (a) a base salary; (b) bonus compensation; and (c) equity participation through the Company’s Stock Option Plan or all such forms of compensation.

 

101
 

 

Base Salary

 

In the view of Company, paying base salaries which are competitive in the markets in which the Company operates is a first step to attracting and retaining talented, qualified and effective executives. Competitive salary information on companies earning comparative revenues in a similar industry is compiled from a variety of sources, including surveys conducted by independent consultants and national and international publications.

 

Bonus Compensation

 

The Company’s primary objective is to achieve certain strategic objectives and milestones. The Company may approve executive bonus compensation dependent upon the Company meeting those strategic objectives and milestones and sufficient cash resources being available for the granting of bonuses. Bonuses paid to the executive officers are allocated on an individual basis. Bonuses are paid to reward work done above the base level of expectations set by the base salary, wages or contractor payments. There were no bonuses paid to any of NEOs during the most recently completed financial year.

 

Equity Participation through Stock Option Plan

 

The Company has, as a part of its long-term incentive, adopted a Stock Option Plan. The Stock Option Plan is designed to encourage share ownership and entrepreneurship on the part of the senior management and other employees. The Compensation Committee believes that the Stock Option Plan aligns the interests of the NEOs with shareholders by linking a component of executive compensation to the longer-term performance of the Company’s common shares.

 

In monitoring or adjusting the option allotments, the Compensation Committee takes into account the level of options granted for similar levels of responsibility and considers each executive officer or employee based on reports received from management, its own observations on individual performance (where possible) and its assessment of individual contribution to shareholder value, previous options grants and the objectives set for the executive officers. The scale of options will generally be commensurate to the appropriate level of base compensation for each level of responsibility.

 

In addition to determining the number of options to be granted pursuant to the methodology outlined above, the Compensation Committee also makes the following determinations:

 

  The executive officers and others who are entitled to participate in the Company’s Stock Option Plan;

  The exercise price for each stock option granted, subject to the provision that the exercise price cannot be lower than the market price on the date of grant;

  The date on which each option is granted;

  The vesting period, if any, for each stock option; and

  The other material terms and conditions of each stock option grant

 

Stock option grants are designed to reward the executive officers for success on a similar basis as the shareholders of the Company, although the level of reward provided by a particular stock option grant is dependent upon the volatility of the stock market. The Company believes that encouraging its executives and employees to become shareholders is the best way of aligning their interests with those of its shareholders. Equity participation is accomplished through our Stock Option Plan. Stock options are granted to senior executives taking into account a number of factors, including the amount and term of options previously granted, base salary and bonuses and competitive factors. Options are generally granted to senior executives which vest immediately.

 

All of the executive officers are entitled to participate in our Stock Option Plan.

 

102
 

 

Pension Plan Benefits

 

The Company does not have a pension plan in place and therefore there were no pension plan benefit awards made to a director or Executive Officer.

 

Employment Agreements with Executive Officers and Significant Employees

 

On October 12, 2016, the Company entered into an employment agreement with Dr. William V. Williams, effective October 31, 2016, to serve as Chief Executive Officer and President. Dr. William V. Williams is also a member of our board of directors. His agreement automatically renews for one (1) year terms every October 31st unless cancelled by either Dr. Williams or the Company. Pursuant to the agreement, Dr. William V. Williams is paid a base fee of USD $175,000 and received 2,107 stock options on the date of his appointment and exercisable at $60.00 per share. The agreement also provides for milestone incentive bonuses which may increase the remuneration by an additional $50,000 USD. If the agreement is terminated by the Company, all amounts accrued under the agreement shall become due and a lump sum termination fee equal to the pro rata monthly salary times the number of months employed divided by 2 (subject to a maximum of 12) shall become payable. The agreement may be terminated by Dr. William V. Williams upon delivery of 30 days written notice.

 

The amounts payable pursuant to the employment agreement with Dr. William V. Williams is incurred in US dollars. The Company converts the US dollar amounts in Canadian equivalents using an exchange rate for the date on which Dr. William V. Williams is paid pursuant to Dr. Williams’ employment agreement.

 

Effective November 1, 2016, the Company entered into a consulting agreement with Gadi Levin (the “Levin Agreement”). Under the Levin Agreement, Mr. Gadi Levin agreed to serve as Chief Financial Officer of the Company for a one (1) year term, renewable upon written agreement. Pursuant to the Levin Agreement, Mr. Gadi Levin receives a fee of $3,500 per month. Either party may terminate the Levin Agreement for reason of default on fifteen (15) days’ written notice (unless the default is cured within that period), or without cause on thirty (30) days’ notice. Upon termination, Mr. Gadi Levin is entitled to payment for work performed and accepted.

 

On July 3, 2015, the Company entered into an employment agreement, effective July 13, 2015, with Markus Lacher, Ph.D. (the “Lacher Agreement”), to serve as the Company’s Senior Director of Research and Development. Mr. Lacher’s employment is an at “at-will” employment with no specific term. Pursuant to the Lacher Agreement, Mr. Lacher is paid an annual salary of $105,000 and received 1,667 stock options on the date of his appointment that are exercisable at $75.00 per share. The Lacher Agreement also provides for milestone incentive bonuses that are developed by the Company on an annual basis. Upon the termination of the Lacher Agreement, Mr. Lacher shall be entitled to receive payment for all unpaid salary, accrued but unpaid bonuses, if any, and vacation accrued as of the date of termination. Dr. Lacher terminated his employment with BriaCell on August 23, 2020.

 

103
 

 

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

 

The following table sets forth information with respect to the beneficial ownership of our common shares as of December 10, 2020 by:

 

  each person, or group of affiliated persons, known to us to be the beneficial owner of more than 5% of our outstanding common shares;

 

  each of our directors and executive officers; and

 

  all of our directors and executive officers as a group.

 

The beneficial ownership of our common shares is determined in accordance with the rules of the SEC and generally includes any shares over which a person exercises sole or shared voting or investment power, or the right to receive the economic benefit of ownership. For purposes of the table below, we deem common shares issuable pursuant to options and warrants that are currently exercisable or exercisable within 60 days of December 10, 2020 to be outstanding and to be beneficially owned by the person holding the options for the purposes of computing the percentage ownership of that person, but we do not treat them as outstanding for the purpose of computing the percentage ownership of any other person.

 

The percentage of shares beneficially owned has been computed on the basis of 771,962 common shares outstanding as of December 10, 2020.

 

Unless otherwise noted below, the address of each shareholder, director and executive officer is c/o BriaCell Therapeutics Corp. Suite 300 – Bellevue Centre, 235- 15th Street, West Vancouver, BC V7T 2X1.

 

Except as indicated in footnotes to this table, we believe that the shareholders named in this table have sole voting and investment power with respect to all shares shown to be beneficially owned by them, based on information provided to us by such shareholders. The shareholders listed below do not have any different voting rights from any of our other shareholders.

 

   No. of Shares Beneficially Owned   Percentage Owned(5) 
Directors and executive officers:          
William V. Williams (1)   71,538    9.27%
Gadi Levin(2)   1,810    *%
Jamieson Bondarenko (3)   129,856    16.72%
Vaughn C. Embro-Pantalony   9,524    1.23%
Rebecca Taub   -    -%
Charles Wiseman(4)   46,271    5.99%

Martin Schmieg

    -       - %
All directors and executive officers as a group (7 persons)   258,999    32.81%
Sichenzia Ross Ference LLP(5)   

50,000

    

6.48

 

 

* Indicates beneficial ownership of less than 1% of the total common shares outstanding

 

Notes:

 

  1. Includes 2,500 options with an exercise price of $45.00, expiring on March 1, 2021 and 2,152 warrants to purchase common shares with an exercise price of $42.00, expiring on March 27, 2021.
  2. Includes 667 with an exercise price of $45.00, expiring on March 1, 2021 options and 333 warrants to purchase common shares with an exercise price of $42.00, expiring on March 27, 2021.
  3. Includes 6,667 options with an exercise price of $45.00, expiring on March 1, 2021 and 3,333 warrants to purchase common shares.
  4. Includes 1,667 options to purchase common shares with an exercise price of $45.00, expiring on March 1, 2021
  5.

The percentages are calculated based on 771,962 common shares outstanding as at December 10, 2020.

  6. The address of this shareholder is 1185 Avenue of the Americas, 37th Floor, New York, NY 10036.

 

Record Holders

 

Based upon a review of the information provided to us by our transfer agent, as of December 8, there were a total of 49 holders of record of our shares, of which approximately 65% are located in Canada and the remainder, with the exception of 2 overseas holders, are located in the United States.

 

104
 

 

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

 

The following is a description of material transactions, or series of related material transactions since August 1, 2016, to which we are a party and in which the other parties include our directors, executive officers, holders of more than 5% of our voting securities, or any member of the immediate family of any of the foregoing persons.

 

On November 30, 2016, 390 compensation warrants were exercised into 390 common shares and 390 warrants for a total consideration of $21,055.

 

On March 9, 2017 the Company and the Company’s President and CEO, completed a non-brokered private placement financing (the “Offering”) of 18,707 units (the “Units”) for aggregate gross proceeds to the Company in the amount of $1,346,900. Under the Offering, each Unit consisted of one common share in the capital of the Company and one-half of one common share purchase warrant.

 

On August 2, 2017, the Company and the Company’s President and CEO completed a non-brokered private placement resulting in gross proceeds of $631,785. The non-brokered private placement involved the sale of 13,528 units at a price of $48.00 per unit. Each Unit consisted of one common share in the capital of the Company.

 

On July 24, 2017, the Company entered into a definitive share exchange agreement (the “Share Exchange Agreement”) between BriaCell Therapeutics Corp., or BTC, the Company’s US subsidiary, Sapientia and all the shareholders of Sapientia. Sapientia is a biotechnology company based in Havertown, PA, that is developing novel targeted therapeutics for multiple indications including several cancers and fibrotic diseases.

 

Pursuant to the terms of the Share Exchange Agreement, BTC acquired from the Sapientia shareholders all of the issued and outstanding shares in the capital of Sapientia. As consideration, the Sapientia shareholders, received an aggregate of 8,333 common shares in the capital of BriaCell on a pro-rata basis (the “Transaction”), which were issued on September 5, 2017. As part of the Transaction, pursuant to a license agreement entered into with Faller-Williams Technology (“FWT”), dated March 16, 2017, (the “License Agreement”), BriaCell acquired all rights, including composition of matter patents, and preclinical study data to a novel therapeutic technology platform, known as protein kinase C delta (PKCδ) inhibitors, which represents a unique, highly-targeted approach to treat cancer and to boost the immune system. The License Agreement is described in “Description of Business – License Agreements.” A principal of FWT is the brother of our Chief Executive Officer. Sapientia’s shareholders included Dr. Williams and Martin Schmieg, each of whom were directors of the Company at the time of the Share Exchange Agreement.

 

On March 27, 2018, the Company completed a non-brokered private placement (the “March 2018 Non-Brokered Unit Offering”) of 144,408 units of the Company (the “Units”) at a price of $30.00 per Unit for aggregate gross proceeds of $4,332,232. Under the March 2018 Non-Brokered Unit Offering, each Unit consists of one common share (each, a “March Common Share”) and one common share purchase warrant (each, a “March Warrant”). The March Warrants are valid for 36 months following the closing of the Non-Brokered Unit Offering and each March Warrant is exercisable for one March Common Share at an exercise price of $42.00.

 

Concurrent with the March 2018 Non-Brokered Unit Offering, the Company also completed a brokered private placement for the purchase of 5.0% unsecured convertible notes (each, a “March Note”) in the principal amount of US$885,000 (the “March Note Offering”). Under the terms of securities purchase agreements dated March 8, 2018 between the Company and the purchasers of March Notes, each March Note is convertible at the option of the holder into (i) common shares of BriaCell for so long as the March Note is outstanding, at a fixed conversion price of $30.00 per March Common Share, for a period of nine months from the date of issuance, which may be extended by the applicable holder for up to six additional months at the holder’s sole option, and (ii) for each March Common Share resulting from the conversion, one March Warrant. The March Warrants are valid for 36 months from their issuance date and each March Warrant is exercisable for one March Common Share at an exercise price of $42.00.

 

In connection with the Non-Brokered Unit Offering and the Note Offering (together, the “March Offerings”), the Company paid commissions to certain participating dealers on a portion of funds raised. In respect of the March Note Offering, an aggregate cash commissions of $235,215 and an aggregate 8,711 broker warrants (the “Broker Warrants”) were paid. The compensation warrants issued in connection with the March Offerings are exercisable for one March Common Share at an exercise price of $42.00 for a period of 36 months from the issue date.

 

The following directors and officers participated in the March 2018 Non-Brokered Unit Offering.

 

Name  Amount invested   Number of shares 
Saeid Babaei (1)  $15,000    500 
Rahoul Sharan(2)  $50,000    1,667 
William V. Williams  $64,560    2,135 
Martin E. Schmieg(3)  $10,000    333 
Gadi Levin  $10,000    333 

 

  (1) Resigned on March 18, 2019
  (2) Resigned on March 7, 2019
  (3) Resigned on March 14, 2019 and rejoined on November 24, 2020.

 

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On March 25, 2019 and April 1, 2019, the Company completed a non-brokered private placement (the “March 2019 Private Placement”) on of 99,117 shares of the Company at a price of $30.00 per share for aggregate gross proceeds of $2,973,524 (net proceeds: $2,845,784). As part of the March 2019 Private Placement, Mr. Bondarenko invested $500,000 and received 16,667 common shares.

 

On February 26, 2019, BriaCell sold $500,000 of common shares to Mr. Bondarenko.

 

On September 9, 2019 the Company completed non brokered private placement of 40,300 common shares at a price of $21.00 per common share for gross proceeds of $846,300.

 

The following directors and officers participated in the September 2019 Private Placement.

 

Name  Amount invested   Number of shares 
William V. Williams  $453,269    21,584 
Jamieson Bondarenko  $220,801    10,514 
Mr. Vaughn C. Embro-Pantalony  $100,000    4,762 
Gadi Levin  $10,000    476 

 

On October 15, 2019, the Company completed non brokered private placement of 27,069 common shares at a price of $21 per common share for gross proceeds of $568,444.

 

The following directors and officers participated in the October 2019 Private Placement.

 

Name  Amount invested   Number of shares 
William V. Williams  $150,000    7,143 
Jamieson Bondarenko  $150,000    7,143 
Mr. Vaughn C. Embro-Pantalony  $100,000    4,762 

 

On December 3, 2019, the Company received an unsecured US$100,000 loan from ClearIt, LLC, which bears interest at 2.5% annually. The repayment of the loan was due on or before March 26, 2020, after which the interest rate on any remaining due but unpaid balance would increase to 15% annually. On October 15, 2020, the creditor deferred the increased interest start date from March 26, 2020 to November 21, 2020. Martin Schmieg, a Company director, is the General Manager and Chief Executive Officer of ClearIt, LLC. Mr. Schmeig was not a director of the Company at the time this transaction occurred.

 

On January 27, 2020, the Company received an unsecured US$50,000 loan from ClearIt, LLC which bears interest at 2.5% annually. The repayment of the loan was due on or before March 26, 2020, after which the interest rate on any remaining due but unpaid balance would increase to 15% annually. On October 15, 2020, the creditor deferred the increased interest start date from March 26, 2020 to November 21, 2020. Mr. Schmeig was not a director of the Company at the time this transaction occurred.

 

On February 20, 2020, the Company received an unsecured US$50,000 loan from ClearIt, LLC which bears interest at 2.5% annually. The repayment of the loan was due on or before March 26, 2020, after which the interest rate on any remaining due but unpaid balance would increase to 15% annually. On October 15, 2020, the creditor deferred the increased interest start date from March 26, 2020 to November 21, 2020. Mr. Schmeig was not a director of the Company at the time this transaction occurred.

 

As at July 31, 2020, included in accounts payable and accrued liabilities are amounts owing to a company controlled by an officer in the amount of $52,500 for consulting fees and an amount owing to a director of $615,749 charged by directors and key management personnel or companies controlled by these individuals:

 

Issuance date   Year Ended
July 31, 2020
    Year Ended
July 31, 2019
 
Paid or accrued professional fees to a company controlled by an on officer of the Company   $ 42,000 (1)   $ 42,000 (1)
Paid or accrued consulting fees to companies controlled by individual directors   $ 56,804 (2)   $ 121,112 (2)
Paid or accrued wages and consulting fees to directors   $ 541,310 (3)   $ 280,938 (3)
Share based compensation to directors and officers   $ -     $ -  

 

  1. Paid or accrued consulting fees to a company, controlled by Mr. Levin, the Company’s Chief Financial Officer.
  2. Paid or accrued consulting to Ameretat Investment Ltd, a company controlled by Saeid Babaei, a director and KJN Management Ltd, a company controlled by Rahoul Sharan and JGRNT Capital Corp., a Company controlled by Mr. Jamieson Bondarenko or to Mr. Jamieson Bondarenko.
  3. Paid or accrued wages to directors: Dr. Charles Wiseman, Dr. Willam V. Williams, Mr. Martin Schmieg and Mr. Vaughn C. Embro-Pantalony.
  4. Share-based compensation in respect of stock options issued during the period to five directors: Dr. Saeid Babaei, Mr. Rahoul Sharan, Mr. Isaac Maresky, Dr. William V. Williams and Dr. Joseph Wagner.

 

These transactions were in the normal course of operations and were measured at the exchange value which represented the amount of consideration established and agreed to by the related parties.

 

In August 2020, BriaCell issued 50,000 restricted common shares to Sichenzia Ross Ference LLP as compensation for legal services.

 

106
 

 

DESCRIPTION OF SECURITIES

 

The following description of securities offered in this offering and provisions of our Articles of Incorporation is a summary and does not purport to be complete.

 

Common Units

 

Each Common Units being offered in this offering consists of one common share and one Warrant, each Warrant exercisable for one common share. The common shares and Warrants that are part of the Common Units are immediately separable and will be issued separately in this offering, although they will have been purchased together in this offering.

 

Common Shares

 

As of December 10, 2020, our authorized share capital, as provided for by our articles, consists of an unlimited number of common shares, without par value, of which approximately 771,962 shares are issued and outstanding. Upon the closing of this offering our authorized share capital is to consist of an unlimited amount of common shares, without par value, of which we expect 4,040,727 will be issued and outstanding (assuming that the underwriters do not exercise their option to purchase additional Common Units and assuming no sale of Pre-funded Warrants). All of our outstanding common shares are validly issued, fully paid and non-assessable.

 

Our common shares are the only securities with respect to which a voting right may be exercised at a meeting of shareholders.

 

Dividends. Our Shareholders are entitled to receive dividends, as may be declared from time to time and in the sole discretion of the Board. Dividends shall be paid according to the number of Common Shares owned. Dividends may take the form of specific assets or of fully paid shares or of bonds, debentures or other securities of the Company, or in any one or more of those ways. Shareholders are not entitled to notice of any dividend. We have never paid cash dividends on our capital stock and we do not anticipate paying any dividends in the foreseeable future.

 

Voting Rights. Each common share is entitled to one vote at a meeting of shareholders.

 

Pre-Funded Warrants

 

The following summary of certain terms and provisions of the Pre-funded Warrants that are being offered hereby is not complete and is subject to, and qualified in its entirety by the provisions of, the Pre-funded Warrant. Prospective investors should carefully review the terms and provisions of the form of Pre-funded Warrant for a complete description of the terms and conditions of the Pre-funded Warrants.

 

The term “pre-funded” refers to the fact that the purchase price of our common share in this offering includes almost the entire exercise price that will be paid under the Pre-funded Warrants, except for a nominal remaining exercise price of US$0.01. The purpose of the Pre-funded Warrants is to enable investors that may have restrictions on their ability to beneficially own more than 4.99% (or, upon election of the holder, 9.99%) of our outstanding common shares following the consummation of this offering the opportunity to make an investment in the Company without triggering their ownership restrictions, by receiving Pre-funded Warrants in lieu of our common shares which would result in such ownership of more than 4.99% (or 9.99%), and receive the ability to exercise their option to purchase the shares underlying the Pre-funded Warrants at such nominal price at a later date.

 

Duration. The Pre-funded Warrants offered hereby will entitle the holders thereof to purchase our common shares at a nominal exercise price of US$0.01 per share, commencing immediately on the date of issuance. There is no expiration date for the Pre-funded Warrants.

 

Exercise Limitation. A holder will not have the right to exercise any portion of the Pre-funded Warrant if the holder (together with its affiliates) would beneficially own in excess of 4.99% (or, upon election of the holder, 9.99%) of the number of our common shares outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Pre-funded Warrants. However, any holder may increase or decrease such percentage, provided that any increase will not be effective until the 61st day after such election. It is the responsibility of the holder to determine whether any exercise would exceed the exercise limitation.

 

Exercise Price. The Pre-funded Warrants will have an exercise price of $0.01 per share. The exercise price is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our common shares and also upon any distributions of assets, including cash, stock or other property to our shareholders.

 

Transferability. Subject to applicable laws, the Pre-funded Warrants may be offered for sale, sold, transferred or assigned without our consent.

 

Absence of Trading Market. There is no established trading market for the Pre-funded Warrants and we do not expect a market to develop. In addition, we do not intend to apply for the listing of the Pre-funded Warrants on any national securities exchange or other trading market. Without an active trading market, the liquidity of the Pre-funded Warrants will be limited.

 

Fundamental Transactions. In the event of a fundamental transaction, generally including any reorganization, recapitalization or reclassification of our common shares, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidation, merger, amalgamation or arrangement with or into another person, the acquisition of more than 50% of our outstanding common shares, or any person or group becoming the beneficial owner of 50% of the voting power represented by our outstanding common shares, the holder shall have the right to receive, for each common share that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental transaction, the number of common share of the successor or acquiring corporation or of us if we are the surviving corporation, and any additional consideration receivable as a result of such fundamental transaction by a holder of the number of common shares for which the Pre-funded Warrant was exercisable immediately prior to such fundamental transaction.

 

No Rights as a Shareholder. Except as otherwise provided in the Pre-funded Warrants or by virtue of such holder’s ownership of our common shares, the holder of a Pre-funded Warrants does not have the rights or privileges of a holder of our common shares, including any voting rights, until the holder exercises the pre-funded Warrant.

 

Warrants Included in the Common Units and Pre-funded Warrants

 

The Warrants included within the Common Units and Pre-funded Units are exercisable immediately, have an exercise price of US$___ per share, equal to 125% of the public offering price of one unit, and expire five years from the date of issuance.

 

No fractional shares or scrip representing fractional shares shall be issued upon the exercise of the Warrants. As to any fraction of a share which the holder would otherwise be entitled to purchase upon such exercise, we shall, at our election, either pay a cash adjustment in respect of such fraction (in an amount equal to such fraction multiplied by the exercise price) or round the number of shares to be received by the holder up to the next whole number.

 

Registration Number

 

Our registration number under the BCBCA is BC0764547.

 

Certain Important Provisions of our Articles and the BCBCA

 

The following is a summary of certain important provisions of our articles and certain related sections of the BCBCA. Please note that this is only a summary and is not intended to be exhaustive. This summary is subject to, and is qualified in its entirety by reference to, the provisions of our articles and the BCBCA.

 

Directors

 

Power to vote on matters in which a director is materially interested. Under the BCBCA a director who has a material interest in a contract or transaction, whether made or proposed, that is material to us, must disclose such interest to us, subject to certain exceptions such as if the contract or transaction: (i) is an arrangement by way of security granted by us for money loaned to, or obligations undertaken by, the director for our benefit or for one of our affiliates’ benefit; (ii) relates to an indemnity or insurance permitted under the BCBCA; (iii) relates to the remuneration of the director in his or her capacity as director, officer, employee or agent of our company or of one of our affiliates; (iv) relates to a loan to our company while the director is the guarantor of some or all of the loan; or (v) is with a corporation that is affiliated to us while the director is also a director or senior officer of that corporation or an affiliate of that corporation.

 

A director who holds such disclosable interest in respect of any material contract or transaction into which we have entered or propose to enter may be required to absent himself or herself from the meeting while discussions and voting with respect to the matter are taking place. Directors are also required to comply with certain other relevant provisions of the BCBCA regarding conflicts of interest.

 

107
 

 

Directors’ power to determine the remuneration of directors. The remuneration of our directors is determined by our directors subject to our Articles. If the directors so decide, the remuneration of the directors, if any, will be determined by the shareholders. The remuneration may be in addition to any salary or other remuneration paid to any of our employees (including executive officers) who are also directors.

 

Director’s power to vote on a proposal, arrangement or contract in which the director is materially interested. A director or senior officer who holds any office or possesses any property, right or interest that could result, directly or indirectly, in the creation of a duty or interest that materially conflicts with that individual’s duty or interest as a director or senior officer, must disclose the nature and extent of the conflict as required by the BCBA. A director who holds a disclosable interest in a contract or transaction into which the Company has entered or proposes to enter is not entitled to vote on any directors’ resolution to approve that contract or transaction, unless all the directors have a disclosable interest in that contract or transaction, in which case any or all of those directors may vote on such resolution. A director who holds a disclosable interest in a contract or transaction into which the Company has entered or proposes to enter and who is present at the meeting of directors at which the contract or transaction is considered for approval may be counted in the quorum at the meeting whether or not the director votes on any or all of the resolutions considered at the meeting.

 

Number of shares required for director’s qualification. Directors do not need to own stock of the Company to qualify to be a Director.

 

Shareholder Meetings

 

Subject to applicable stock exchange requirements, we must hold a general meeting of our shareholders at least once every year at a time and place determined by our board of directors, provided that the meeting must not be held later than 15 months after the preceding annual general meeting. A meeting of our shareholders may be held anywhere in or outside British Columbia.

 

A notice to convene a meeting, specifying the date, time and location of the meeting, and, where a meeting is to consider special business, the general nature of the special business must be sent to each shareholder entitled to attend the meeting and to each director not less than 21 days and no more than two months prior to the meeting, although, as a result of applicable securities laws, the minimum time for notice is effectively longer in most circumstances. Under the BCBCA, shareholders entitled to notice of a meeting may waive or reduce the period of notice for that meeting, provided applicable securities laws are met. The accidental omission to send notice of any meeting of shareholders to, or the non-receipt of any notice by, any person entitled to notice does not invalidate any proceedings at that meeting.

 

Our Articles provide that a quorum for the transaction of business at a meeting of our shareholders is met where there are two persons who are, or who represent by proxy, shareholders who, in the aggregate, hold at least 5% of the issued shares entitled to vote. If, however, such quorum shall not be present or represented at any meeting of the shareholders, the shareholders entitled to vote thereat, present in person or represented by proxy, shall have power to adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum shall be present or represented. At such adjourned meeting at which a quorum shall be present or represented, any business may be transacted which might have been transacted at the meeting as originally notified.

 

Pursuant to our articles, a quorum for meetings of shareholders is present if two shareholders who, in the aggregate, hold at least 5% of the issued shares entitled to be voted at the meeting are present in person or represented by proxy. If a quorum is not present at the opening of any meeting of shareholders, the meeting stands adjourned to the same day in the next week at the same time and place, unless the meeting is requisitioned by shareholders, in which case the meeting is dissolved. When a quorum is present or represented at any meeting, the vote of the holders of a majority of the stock having voting power present in person or represented by proxy shall be sufficient to elect directors or to decide any question brought before such meeting, unless the question is one upon which by express provision of the statutes or of the Articles, a different vote is required in which case such express provision shall govern and control the decision of such question.

 

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Each shareholder of record of the corporation shall be entitled at each meeting of shareholders to one vote for each share of stock standing in his name on the books of the corporation. Upon the demand of any shareholder, the vote for directors and the vote upon any question before the meeting shall be by ballot.

 

At any meeting of the shareholders any shareholder may be represented and vote by a proxy or proxies appointed by an instrument in writing. In the event that any such instrument in writing shall designate two or more persons to act as proxies, a majority of such persons present at the meeting, or, if only one shall be present, then that one shall have and may exercise all of the powers conferred by such written instrument upon all of the persons so designated unless the instrument shall otherwise provide. No proxy or power of attorney to vote shall be used to vote at a meeting of the shareholders unless it shall have been filed with the secretary of the meeting when required by the inspectors of election. All questions regarding the qualification of voters, the validity of proxies and the acceptance or rejection of votes shall be decided by the inspectors of election who shall be appointed by the Board of Directors, or if not so appointed, then by the presiding officer of the meeting.

 

Any action which may be taken by the vote of the shareholders at a meeting may be taken without a meeting if authorized by the written consent of shareholders holding at least a majority of the voting power, unless the provisions of the statutes or of the Articles of Incorporation require a greater proportion of voting power to authorize such action in which case such greater proportion of written consents shall be required.

 

Shareholder Proposals

 

Under the BCBCA, qualified shareholders holding at least one percent (1%) of our issued voting shares may make proposals for matters to be considered at the annual general meeting of shareholders. Such proposals must be sent to us in advance of any proposed meeting by delivering a timely written notice in proper form to our registered office in accordance with the requirements of the BCBCA and be accompanied by one written statement in support of the proposal. The notice must include information on the business the shareholder intends to bring before the meeting.

 

Forum Selection

 

We have not included a forum selection provision in our articles.

 

Ownership Limitation and Transfer of Shares

 

Our fully paid common shares in registered form and may be freely transferred under our articles of incorporation, unless the transfer is restricted or prohibited by another instrument, applicable law or the rules of a stock exchange on which the shares are listed for trade. The ownership or voting of our common shares by non-residents of Canada is not restricted in any way by our articles of incorporation or the laws of Canada.

 

Share Transfers

 

Pursuant to our Articles, a transfer of a share must not be registered unless:

 

  (a) Except as exempted by the BCBCA, a duly signed proper instrument of transfer in respect of the share has been received by the Company;
  (b) If a share certificate has been issued by the Company in respect of the share to be transferred, that share certificate has been surrendered to the Company; and
  (c) if a non-transferable written acknowledgment of the shareholder’s right to obtain a share certificate has been issued by the Company in respect of the share to be transferred, that acknowledgment has been surrendered to the Company.

 

Change in Control

 

Our articles of incorporation do not contain restrictions on change in control.

 

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Election of Directors

 

Our common shares do not have cumulative voting rights for the election of directors. As a result, the holders of a majority of the voting power represented at a shareholders meeting have the power to elect all of our directors.

 

The directors shall be elected at the annual meeting of the shareholders by a simple majority vote of holders of our voting shares, participating and voting at such meeting, and each director elected shall hold office until his successor is elected and qualified. However, in the event of any vacancy in the Board, including those caused by an increase in the number of Directors, such vacancy may be filled by a majority of the remaining directors, though less than a quorum, or by a sole remaining director, and each director so elected shall hold office until his successor is elected at an annual or a special meeting of the shareholders. The holders of a two-thirds of the outstanding shares of stock entitled to vote may at any time peremptorily terminate the term of office of all or any of the directors by vote at a meeting called for such purpose or by a written statement filed with the secretary or, in his absence, with any other officer. Such removal shall be effective immediately, even if successors are not elected simultaneously and the vacancies on the Board of Directors resulting therefrom shall be filled only by the shareholders.

 

A vacancy or vacancies in the Board of Directors shall be deemed to exist in case of the death, resignation or removal of any directors, or if the authorized number of directors be increased, or if the shareholders fail at any annual or special meeting of shareholders at which any director or directors are elected to elect the full authorized number of directors to be voted for at that meeting.

 

The shareholders may elect a director or directors at any time to fill any vacancy or vacancies not filled by the directors. If the Board of Directors accepts the resignation of a director tendered to take effect at a future time, the Board or the shareholders shall have power to elect a successor to take office when the resignation is to become effective.

 

No reduction of the authorized number of directors shall have the effect of removing any director prior to the expiration of his term of office.

 

Anti-Takeover Measures

 

Our articles of incorporation do not provide for any anti-takeover measures.

 

Changes in Capital

 

Our articles of incorporation enable us to increase or reduce our share capital. Any such changes are subject to the provisions of the BCBCA.

 

We have had no change in share capital in the prior three years other than increasing the number of issued and outstanding common shares as described elsewhere in this prospectus.

 

Exchange Controls

 

The BCBCA and our articles of incorporation do not provide for any restriction in connection with the following:

 

  (1) the import or export of capital, including the availability of cash and cash equivalents for use by the company’s group; and
     
  (2) the remittance of dividends, interest or other payments to nonresident holders of the company’s securities.

 

Transfer Agent and Registrar

 

Our transfer agent is Computershare Investor Services Inc., 3rd Floor, 510 Burrard Street, Vancouver, British Columbia V6C 3B9, telephone: (604) 661-9474, facsimile: (604) 661-9401.

 

Listing

 

We are in the process of applying to have our common shares and Warrants listed on The Nasdaq Capital Market under the symbols “BCTX” and “BCTXW”, respectively. Our common shares are currently quoted on the OTCQB marketplace under the symbol “BCTXF” and listed on the TSX Venture Exchange under the symbol “BCT”. We do not plan to have the Pre-funded Warrants listed on any exchange or marketplace.

 

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Derivative Securities

 

Options and Incentive Plans and Awards

 

The Company’s Stock Option Plan (the “Plan”) was previously approved by the shareholders at the Company’s annual and special meeting on November 25, 2014. Pursuant to the Plan, the Company is authorized to grant options to officers, directors, employees and consultants enabling them to acquire up to 10% of the issued and outstanding Common Shares of the Company. The options can be granted for a maximum of 5 years and vest as determined by the Board. The exercise price of each option granted may not be less than the fair market value of the Common Shares at the time of grant.

 

Pursuant to the policies of the TSX Venture Exchange (the “TSXV”), the Company is required to obtain.

 

shareholder approval of the Stock Option Plan each year because the Stock Option Plan is a rolling maximum option plan whereby the maximum number of Common Shares that may be reserved for issuance and which can be purchased upon the exercise of all options granted under the Stock Option Plan is fixed at 10% of the outstanding Common Shares from time to time.

 

Summary of the Plan

 

  The term of any options granted under the Plan will be fixed by the Board at the time such options are granted, provided that options will not be permitted to exceed a term of five years (or ten years if the Company is reclassified by the TSXV as a Tier 1 Issuer).
  The exercise price of any options granted under the Plan will be determined by the Board, in its sole discretion, but shall not be less than the closing price of the Company’s Common Shares on the day preceding the day on which the directors grant such options, less any discount permitted by the TSXV.
  No vesting requirements will apply to options granted hereunder, however a four month hold period will apply to all Common Shares issued under each option, commencing from the date of grant.
  All options are non-transferable.
  Options will be adjusted and/or reclassified (as applicable) in the event of any consolidation, subdivision, conversion or exchange of the Company’s Common Shares.
  No more than 5% of the issued Common Shares may be granted to any one individual in any 12 month period.
  No more than 2% of the issued Common Shares may be granted to a consultant, or any employee performing investor relations activities, in any 12 month period
  Disinterested shareholder approval must obtain if:

 

  i. A stock option plan, together with all of the Company’s previously established and outstanding stock option plans or grants, could result at any time in:
         
      a) The number of shares reserved for issuance under stock options granted to Insiders (as such term is defined in the policies of the TSXV) exceeding 10% of the issued Common Shares;
      b) the grant to Insiders, within a 12 month period, of a number of options exceeding 10% of the issued Common Shares; or
      c) the issuance to any one optionee, within a 12 month period, of a number of shares
      d) exceeding 5% of the issued Common Shares; or
         
  ii. the Company is decreasing the exercise price of stock options previously granted to Insiders.

 

The following table sets forth certain information pertaining to the Company’s equity compensation plan as at the end of the Company’s financial year on July 31, 2020.

 

Plan Category  Number of securities issuable upon exercise of outstanding options, warrants and rights   Weighted-average exercise price of outstanding warrants and rights   Number of securities remaining available for future issuance under equity compensation plans (excluding securities to be issued upon exercise of outstanding options, warrants and rights)(1) 
Equity compensation plans approved by security holders    213,199    $ 44.90      52,227  
Equity compensation plans not approved by security holders   -    -    - 

 

  1. Based on a total of 72,196 options issuable pursuant to our Stock Option Plan, representing 10% of the Company’s issued and outstanding share capital of 72,196 common shares as at July 31, 2020, less the total number of options already issued.

 

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Warrants

 

As of December 10, 2020, warrants outstanding were as follows:

 

Number of

Warrants Outstanding

  Exercise Price     Exercisable At
December 10, 2020
    Expiry Date
11,404   $ 90.00       11,404     April 26, 2021
141,074   $ 42.00       141,074     March 27, 2021
26,050   $ 36.00       26,050     July 2021 to April 2022
74,078   $ 5.42       -     November 17, 2025
252,606             178,528      

 

Compensation Warrants

 

As at December 10, 2020, compensation warrants outstanding were as follows:

 

Number Of            
Compensation   Exercise   Exercisable at    
Warrants Outstanding   Price  

December 10, 2020

   Expiry Date
 912   $90.00    912   April 26, 2021 (i)
 4,167   $42.00    4,167   March 27, 2021 (ii)
 8,711   $42.00    8,711   March 27, 2021 (ii)
 13,790         13,790    

 

  i. Each compensation warrant can be exercised at $90.00 into one unit of BriaCell comprising of one common share and one share purchase warrant. Each resultant share purchase warrant acquired can be exercised into an additional common share of BriaCell at $105.00 if exercised by April 26, 2021.
  ii. Each compensation warrant can be exercised at $42.00 into one common share of BriaCell for a period of 36 months.

 

SHARES ELIGIBLE FOR FUTURE SALE

 

Upon completion of this offering, we will have 4,040,727 common shares outstanding (assuming that the underwriters do not exercise their option to purchase additional Common Units and assuming no sale of Pre-funded Warrants, or any shares that may be sold pursuant to the underwriter’s over-allotment option). All of the common shares sold in this offering and the common shares sold by the selling shareholder will be freely transferable by persons other than by our “affiliates” without restriction or further registration under the Securities Act. Sales of substantial amounts of our common share in the public market could adversely affect prevailing market prices of our common share. Prior to this offering, there has been a limited public market for our common share. We have applied to list the common shares and Warrants on the Nasdaq Capital Market, but we cannot assure you that our application will be approved or a regular trading market will develop in the common shares or Warrants.

 

Additionally, we have 18,052 options and 266,396 warrants outstanding as of December 10, 2020. The exercise price of the majority of these options and warrants is significantly above our current market price.

 

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Rule 144

 

Certain of our common shares that will be outstanding upon the completion of this offering, other than those common shares sold in this offering, are “restricted securities” as that term is defined in Rule 144 under the Securities Act and may be sold publicly in the United States only if they are subject to an effective registration statement under the Securities Act or pursuant to an exemption from the registration requirement such as those provided by Rule 144 and Rule 701 promulgated under the Securities Act. In general, beginning 90 days after the date of this prospectus, a person (or persons whose shares are aggregated) who at the time of a sale is not, and has not been during the three months preceding the sale, an affiliate of ours and has beneficially owned our restricted securities for at least six months will be entitled to sell the restricted securities without registration under the Securities Act, subject only to the availability of current public information about us, and will be entitled to sell restricted securities beneficially owned for at least one year without restriction. Persons who are our affiliates and have beneficially owned our restricted securities for at least six months may sell a number of restricted securities within any three-month period that does not exceed the greater of the following:

 

  1% of the then outstanding common shares of the same class, which immediately after this offering will equal approximately common shares assuming the over-allotment option is not exercised; or
  If our common shares are listed on a national securities exchange, the average weekly trading volume of our common share, during the four calendar weeks preceding the date on which notice of the sale is filed with the SEC

 

Sales by our affiliates under Rule 144 are also subject to certain requirements relating to manner of sale, notice and the availability of current public information about us.

 

Rule 701

 

In general, under Rule 701 of the Securities Act as currently in effect, each of our employees, consultants or advisors who purchases our common share from us in connection with a compensatory stock plan or other written agreement executed prior to the completion of this offering is eligible to resell those common shares in reliance on Rule 144, but without compliance with some of the restrictions, including the holding period, contained in Rule 144. However, the Rule 701 shares would remain subject to lock-up arrangements and would only become eligible for sale when the lock-up period expires.

 

Lock-Up Agreements

 

All of our directors and executive officers have signed lock-up agreements. Pursuant to such lock-up agreements, such persons have agreed, subject to certain exceptions, not to sell or otherwise dispose of common shares or any securities convertible into or exchangeable for common shares for a period of six months after the date of this prospectus without the prior written consent of the underwriters, in their sole discretion, at any time, release all or any portion of the common shares from the restrictions in any such agreement.

 

TAXATION

 

The following description is not intended to constitute a complete analysis of all tax consequences relating to the acquisition, ownership and disposition of our common shares, Pre-funded Warrants and Warrants. You should consult your own tax advisor concerning the tax consequences in your particular situation, as well as any tax consequences that may arise under the laws of any taxing jurisdiction.

 

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Certain Canadian Federal Income Tax Considerations For United States Residents

 

The following is, at the date of this prospectus, a summary of certain Canadian federal income tax considerations generally applicable to a holder who acquires, as beneficial owner:

 

  (a) common shares and Warrants comprising the Common Units pursuant to this prospectus, and common shares upon exercise of such Warrant; or
     
  (b) Pre-funded Warrants and Warrants comprising the Pre-funded Units pursuant to this prospectus, and common shares upon exercise of such Pre-funded Warrant and Warrant (collectively all common shares, Warrants and Pre-funded Warrants issued pursuant to the Common Units and Pre-funded Units as well as all common shares issuable pursuant to the exercise of such Warrants or Pre-funded Warrants are referred to in this summary as the “Securities” or “Security”, as applicable, and collectively all Pre-funded Warrants and Warrants acquired pursuant to a Pre-funded Unit and Common Unit are referred to in this summary as the “Warrants”); and

 

who, at all relevant times, (A) for the purposes of the Income Tax Act (Canada) (the “Tax Act”) (i) is not resident, or deemed to be resident, in Canada, (ii) deals at “arm’s length” with the Company and the underwriters, and is not “affiliated” with either the Company or the underwriters, (iii) holds all Securities as capital property, (iv) does not use or hold any of the Securities in the course of carrying on, or otherwise in connection with, a business carried on or deemed to be carried on in Canada and (v) is not a “registered non-resident insurer” or “authorized foreign bank” (each as defined in the Tax Act), or other holder of special status, and (B) for the purposes of the Canada-U.S. Tax Convention (1980) (the “Tax Treaty”), is a resident of the United States, has never been a resident of Canada, does not have and has not had, at any time, a permanent establishment or fixed base in Canada, and who otherwise qualifies for the full benefits of the Tax Treaty. Holders who meet all of the above criteria are referred to herein as “U.S. Holders”, and this summary only addresses such U.S. Holders.

 

This summary does not apply to a U.S. Holder: (i) that is a “financial institution” for purposes of the “mark-to-market” rules in the Tax Act; (ii) that is a “specified financial institution” (as defined in the Tax Act); (iii) that is a partnership; (iv) where an interest in such U.S. Holder would be a “tax shelter investment” (as defined in the Tax Act); (v) that has elected to determine its Canadian tax results in a foreign currency pursuant to the functional currency reporting rules in the Tax Act; (vi) that is exempt from tax under Part I of the Tax Act; (vii) that has entered or will enter into, in respect of any of the Securities, a “synthetic disposition arrangement” or a “derivative forward agreement” (as those terms are defined in the Tax Act); or (viii) that will receive dividends on any common shares of the Company under or as part of a “dividend rental arrangement” (as defined in the Tax Act). Such U.S. Holders should consult with their own tax advisors to determine the particular Canadian federal income tax consequences to them of acquiring the Securities.

 

This summary is based on the current provisions of the Tax Act in force as of the date of this prospectus, the regulations thereunder in force at the date hereof (the “Regulations”), the current provisions of the Tax Treaty, in force as of the date of this prospectus, and the Company’s understanding of the administrative policies and assessing practices of the Canada Revenue Agency published in writing prior to the date hereof. This summary takes into account all specific proposals to amend the Tax Act and Regulations publicly announced by or on behalf of the Minister of Finance (Canada) prior to the date hereof (the “Proposed Amendments”) and assumes that such Proposed Amendments will be enacted in the form proposed. However, such Proposed Amendments might not be enacted in the form proposed, or at all. This summary does not otherwise take into account or anticipate any changes in law or administrative or assessing practices, whether by legislative, governmental or judicial decision or action, nor does it take into account tax laws of any province or territory of Canada or of any other jurisdiction outside Canada, which may differ significantly from those discussed in this summary.

 

For the purposes of the Tax Act, all amounts relating to the acquisition, holding or disposition of the Securities generally must be converted into Canadian dollars, including interest, dividends, adjusted cost base and proceeds of disposition, using the single daily exchange rate as quoted by the Bank of Canada for the relevant day, or such other rate of exchange that is acceptable to the Canada Revenue Agency.

 

This summary is of a general nature only and is not intended to be, nor should it be construed to be, legal or tax advice to any particular U.S. Holder, and no representation with respect to the Canadian federal income tax consequences to any particular U.S. Holder or prospective U.S. Holder is made. This summary is not exhaustive of all Canadian federal income tax considerations. Accordingly, all prospective purchasers (including U.S. Holders as defined above) should consult with their own tax advisors for advice with respect to their own particular circumstances.

 

Allocation of Purchase Price

 

On the acquisition of a Common Unit, U.S. Holders will be required to allocate the aggregate cost of a Common Unit between the common share and the Warrant comprising the Common Unit on a reasonable basis in order to determine their respective costs for purposes of the Tax Act. The Company intends to allocate as consideration for their issue [$     ] to each common share and [$     ] to each Warrant acquired as part of a Common Unit.

 

On the acquisition of a Pre-funded Unit, U.S. Holders will be required to allocate the aggregate cost of a Pre-funded Unit between the Pre-funded Warrant and the Warrant comprising the Pre-Funded Unit on a reasonable basis in order to determine their respective costs for purposes of the Tax Act. The Company intends to allocate as consideration for their issue [$     ] to each Pre-funded Warrant and [$      ] to each Warrant acquired as part of a Pre-funded Unit.

 

The Company believes that such allocations are reasonable but such allocations will not be binding on the Canada Revenue Agency or a U.S. Holder and the Company expresses no opinion with respect to such allocations.

 

The adjusted cost base to a U.S. Holder of a common share acquired as part of a Common Unit will be determined by averaging the cost of such common share with the adjusted cost base of all common shares of the Company held by the U.S. Holder as capital property immediately before such acquisition.

 

Exercise of Warrants

 

No gain or loss will be realized by a U.S. Holder on the exercise of a Warrant to acquire a common share of the Company (referred to in this summary as a “Warrant Share”). When a Warrant is exercised, the U.S. Holder’s cost of the Warrant Share acquired thereby will be equal to the aggregate of the U.S. Holder’s adjusted cost base of such Warrant and the exercise price paid for the Warrant Share. The U.S. Holder’s adjusted cost base of the Warrant Share so acquired will be determined by averaging the cost of such Warrant Share with the adjusted cost base to the U.S. Holder of all common shares of the Company held as capital property immediately before the acquisition of the Warrant Share.

 

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Expiry of Warrants

 

The expiry of an unexercised Warrant generally will result in a capital loss to the U.S. Holder equal to the adjusted cost base of the Warrant to the U.S. Holder immediately before its expiry. Such capital loss will not be recognized under the Tax Act unless the Warrant constitutes “taxable Canadian property” (see discussion below under the heading “Dispositions of Securities”).

 

Withholding Tax on Dividends

 

Amounts paid or credited or deemed to be paid or credited as, on account or in lieu of payment of, or in satisfaction of, dividends on common shares to a U.S. Holder will be subject to Canadian withholding tax. Under the Tax Act, the rate of withholding is 25% of the gross amount of the dividend. Under the Tax Treaty, the withholding rate on any such dividend beneficially owned by a U.S. Holder that is a resident of the United States for purposes of the Tax Treaty are fully entitled to the benefits of the Tax Treaty in respect of the receipt of such dividend is generally reduced to 15%.

 

Dispositions of Securities

 

A U.S. Holder generally will not be subject to tax under the Tax Act in respect of a capital gain realized on the disposition or deemed disposition of any Securities, nor will capital losses arising therefrom be recognized under the Tax Act, unless such Security constitutes “taxable Canadian property” (as defined in the Tax Act) of the U.S. Holder and the gain is not exempt from tax pursuant to the terms of the Tax Treaty.

 

Provided the common shares of the Company are listed on a “designated stock exchange” (which currently includes the NASDAQ and Tiers 1 and 2 of the TSXV) as defined in the Tax Act and are so listed at the time of disposition, a Security generally will not constitute “taxable Canadian property” of a U.S. Holder at that time unless, at any time during the 60 month period immediately preceding the disposition, the following two conditions are met concurrently: (i) 25% or more of the issued shares of any class or series of shares of the Company were owned by or belonged to one or any combination of: (a) the U.S. Holder, (b) persons with whom the U.S. Holder did not deal at “arm’s length” (within the meaning of the Tax Act), and (c) partnerships in which the U.S. Holder or a person described in (b) holds a membership interest directly or indirectly through one or more partnerships; and (ii) more than 50% of the fair market value of the Security was derived directly or indirectly from one or any combination of; (a) real or immovable property situated in Canada, (b) Canadian resource properties (as defined in the Tax Act), (c) timber resource properties (as defined in the Tax Act) or (d) options in respect of, interests in, or, for civil purposes, a right in, the foregoing property, whether or not such property exists. Notwithstanding the foregoing, a Security may be deemed to be “taxable Canadian property” in certain other circumstances. U.S. Holders should consult their own tax advisors as to whether any of their Securities will constitute “taxable Canadian property”.

 

U.S. Holders who may hold Securities as “taxable Canadian property” should consult their own tax advisors with respect to the application of Canadian capital gains taxation, any potential relief under the Tax Treaty, and special compliance procedures under the Tax Act, none of which is described in this summary.

 

U.S. Federal Income Taxation

 

The following are the material U.S. federal income tax consequences of the acquisition, ownership and disposition of our Common Shares, Pre-Funded Warrants and Warrants (hereinafter sometimes referred to as “our securities”).

 

The discussion below of the U.S. federal income tax consequences to “U.S. Holders” will apply to a beneficial owner of our securities that is for U.S. federal income tax purposes:

 

  an individual citizen or resident of the United States;
     
  a corporation (or other entity treated as a corporation) that is created or organized (or treated as created or organized) in or under the laws of the United States, any state thereof or the District of Columbia;
     
  an estate whose income is includible in gross income for U.S. federal income tax purposes regardless of its source; or
     
  a trust if (i) a U.S. court can exercise primary supervision over the trust’s administration and one or more U.S. persons are authorized to control all substantial decisions of the trust; or (ii) it has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person.

 

A beneficial owner of our securities that is described above is referred to herein as a “U.S. Holder.” If a beneficial owner of our securities is not described as a U.S. Holder and is not an entity treated as a partnership or other pass-through entity for U.S. federal income tax purposes, such owner will be considered a “Non-U.S. Holder.” The material U.S. federal income tax consequences of the acquisition, ownership and disposition of our securities applicable specifically to Non-U.S. Holders are described below under the heading “Non-U.S. Holders.”

 

This discussion is based on the Internal Revenue Code of 1986, as amended (the “Code”), its legislative history, Treasury regulations promulgated thereunder, published rulings and administrative guidance from the Internal Revenue Service (IRS), court decisions and the United States-Canada Income Tax Treaty, all as currently in effect. These authorities are subject to change or differing interpretations, possibly on a retroactive basis.

 

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This discussion does not address all aspects of U.S. federal income taxation that may be relevant to any particular holder based on such holder’s individual circumstances. In particular, this discussion considers only holders that own and hold our securities as capital assets within the meaning of Section 1221 of the Code, and does not address the potential application of the alternative minimum tax or the U.S. federal income tax consequences to holders that are subject to special rules, including:

 

  financial institutions, financial services entities, or underwriters;
     
  broker-dealers, dealers or traders in securities;
     
  persons that are subject to the mark-to-market accounting rules under Section 475 of the Code;
     
  tax-exempt entities;
     
  qualified retirement plans, individual retirement accounts and other tax-deferred accounts;
     
  governments or agencies or instrumentalities thereof;
     
  insurance companies;
     
  regulated investment companies;
     
  real estate investment trusts;
     
  certain expatriates or former long-term residents of the United States;
     
  persons that actually or constructively own (including by treating U.S. Holders of Warrants, Pre-Funded Warrants or other options to acquire our Common Shares as owning such Common Shares) 10% or more of the voting power or value of our Common Shares;
     
  persons that acquired our securities pursuant to an exercise of employee options, in connection with employee incentive plans or otherwise as compensation;
     
  persons that hold our securities as part of a straddle, constructive sale, hedging, conversion or other integrated transaction;
     
  persons whose functional currency is not the U.S. dollar;
     
  passive foreign investment companies; or
     
  controlled foreign corporations.

 

This discussion does not address any aspect of U.S. federal non-income tax laws, such as gift or estate tax laws, or state, local or non-U.S. tax laws or, except as discussed herein, any tax reporting obligations applicable to a holder of our securities. Additionally, this discussion does not consider the tax treatment of partnerships or other pass-through entities or persons who hold our securities through such entities. If a partnership (or other entity classified as a partnership for U.S. federal income tax purposes) is the beneficial owner of our securities, the U.S. federal income tax treatment of a partner in the partnership generally will depend on the status of the partner and the activities of the partnership. This discussion also assumes that any distribution made (or deemed made) to a holder in respect of our securities and any consideration received (or deemed received) by a holder in connection with the sale or other disposition of our securities will be in U.S. dollars. In addition, this discussion also assumes that we will be and have been treated as a foreign corporation for U.S. federal income tax purposes. Moreover, this discussion assumes that a holder will receive only Common Shares and will not be entitled to a fractional share upon the exercise of a Warrant or a Pre-Funded Warrant.

 

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We have not sought, and will not seek, a ruling from the Internal Revenue Service (the “IRS”) or an opinion of counsel as to any U.S. federal income tax consequence described herein. The IRS may disagree with the description of the tax consequences that is provided herein, and its determination may be upheld by a court. Moreover, there can be no assurance that future legislation, regulations, administrative rulings or court decisions will not adversely affect the accuracy of the statements in this discussion.

 

EACH HOLDER OF OUR SECURITIES IS URGED TO CONSULT ITS OWN TAX ADVISOR WITH RESPECT TO THE PARTICULAR TAX CONSEQUENCES TO SUCH HOLDER OF THE ACQUISITION, OWNERSHIP AND DISPOSITION OF OUR SECURITIES, INCLUDING THE APPLICABILITY AND EFFECT OF ANY STATE, LOCAL, AND NON-U.S. TAX LAWS, AS WELL AS U.S. FEDERAL TAX LAWS AND ANY APPLICABLE TAX TREATIES.

 

Tax Characterization of Pre-Funded Warrants

 

Although the appropriate characterization of Pre-Funded Warrants under the tax law is unsettled, it is likely that the Pre-Funded Warrants will be treated as Common Shares for U.S. federal income tax purposes. However, it is possible that the IRS could treat the Pre-Funded Warrants as warrants to acquire our Common Shares. Any person that elects to receive Pre-Funded Units in lieu of the Units in this offering should consult their own tax advisor regarding the application of the U.S. federal income tax laws to their particular situation. The following discussion assumes our Pre-Funded Warrants are properly treated as a class of our Common Shares.

 

Allocation of Purchase Price and Characterization of Units

 

For U.S. federal income tax purposes, each unit and pre-funded unit should be treated as an “investment unit” and the purchase price for each investment unit should be allocated between the two components thereof in proportion to their relative fair market values at the time the unit is purchased by the holder. This allocation of the purchase price for each unit will establish the holder’s initial tax basis for U.S. federal income tax purposes in the Common Share or Pre-Funded Warrant, as applicable, and the Warrant included in each unit. The separation of the Common Share or Pre-Funded Warrant, as applicable, and the Warrant included in each unit should not be a taxable event for U.S. federal income tax purposes. Each holder should consult his, her or its own tax advisor regarding the allocation of the purchase price for a unit.

 

U.S. Holders

 

PFIC Status and Significant Tax Consequences

 

Special U.S. federal income tax rules apply to a U.S. Holder that holds stock in a foreign corporation classified as a Passive Foreign Investment Company (“PFIC”) for U.S. federal income tax purposes. In general, a foreign corporation is treated as a PFIC with respect to a U.S. Holder if, for any taxable year in which such U.S. Holder held stock, either:

 

  at least 75% of its gross income for such taxable year consists of passive income (e.g., dividends, interest, capital gains and rents derived other than in the active conduct of a business); or
     
  at least 50% of the average value of its assets during such taxable year produce, or are held for the production of, passive income.

 

Based upon the value of our assets, including any goodwill, and the nature and composition of our income and assets, we believe we will be classified as a PFIC for the taxable year ending July 31, 2020 and possibly for succeeding years. However, under an exception to the PFIC classification rules, a corporation is not treated as a PFIC for the first taxable year that it has gross income (the “start-up” year) if (i) no predecessor of the corporation was a PFIC, (ii) it is established to the satisfaction of the IRS that the corporation will not be a PFIC for either of the first two taxable years following the start-up year, and (iii) the corporation is in fact not a PFIC for either of the first two taxable years following the start-up year. It is uncertain whether the year ending July 31, 2020 will be considered our start-up year or whether we can meet the other requirements of this rule. Our ability to do so depends on a number of factors: our historic income, the amount of income we generate in the future from investments and from sales, the years in which we generate both types of income, and the ratio of our investment assets to our total assets at the time that we start to generate sales income. If we do meet these requirements we should be able to avoid PFIC status altogether, but there is no assurance that we can do so.

 

If we are classified as a PFIC, a U.S. Holder of our securities will be subject to different taxation rules depending on whether the U.S. Holder (i) takes no action, (ii) makes an election, if permitted, to treat us as a “Qualified Electing Fund” (a “QEF election”) or (iii) if permitted, makes a “mark-to-market” election with respect to our Common Shares. A U.S. Holder of our securities will also be required, under applicable Treasury Regulations, to file an annual information return (Form 8621) containing information regarding our company. Additional explanations of the PFIC rules are set forth below: this material is complex and may affect different U.S. Holders differently. Accordingly, U.S. Holders should consult their own tax advisors about the consequences of our company being classified as a PFIC and about what steps they should take to lessen the tax impact of such PFIC status on them.

 

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Taxation of U.S. Holders Who Do Not Make a Timely QEF or Mark to Market Election (Take No Action)

 

A U.S. Holder of our Common Shares who does not make a timely QEF election or mark-to-market election (a “Non-Electing Holder”), as discussed below, will be subject to the following rules. Any (1) “excess distribution” received from us by the Non-Electing U.S. Holder (an “excess distribution” is the portion of any distributions received by the Non-Electing Holder in a taxable year in excess of 125% of the average annual distributions received by the Non-Electing Holder during the three preceding taxable years or, if shorter, during the Non-Electing Holder’s holding period for our Common Shares), and (2) gain realized on the sale, exchange or other disposition of our Common Shares by the Non-Electing Holder, would be taxed as follows:

 

  the excess distribution, or the gain, would be allocated ratably to each day of the Non-Electing Holders’ aggregate holding period for the our common shares;
     
  the amount allocated to the current taxable year and any prior taxable year before we became a PFIC would be taxed as ordinary income; and
     
  the amount so allocated to each of the prior taxable years would be subject to tax at the highest rate of tax applicable to the taxpayer for such prior year; also interest would be charged on the amount of tax so calculated for such prior year from the due date of the tax for such prior year to the date of payment of the prior year’s tax that arises as a result of the allocation.

 

Assuming that our Pre-Funded Warrants are treated as Common Shares, a U.S. Holder of our Pre-Funded Warrants should be taxed in the same manner as a U.S. Holder of our Common Shares - - both on distributions, if any, with respect to the Pre-Funded Warrants and on a sale of the Pre-Funded Warrants by the U.S. Holder.

 

Holders of Warrants who receive distributions on those Warrants would presumably also be subject to the PFIC rules described above, but (as described below) are apparently not able to make a QEF election (but could make a mark-to-market election). Moreover, under proposed Treasury Regulations which, if finalized, would have a retroactive effect, upon the sale of a Warrant a U.S. Holder would be taxed in the same manner as a U.S. Holder of our Common Shares. Also, under these proposed Treasury Regulations, if a U.S. Holder of Warrants exercises the Warrants to purchase Common Shares, any income realized following the exercise is allocated over a holding period which includes the holding period of the Warrants. Because of the complexity and uncertainty of the treatment of Warrants under the PFIC rules, each U.S. Holder should consult his own tax advisor regarding the application of the PFIC rules to the common shares acquired upon an exercise of Warrants and the availability of, and procedure for making, a qualifying election with respect to Warrants.

 

Taxation of U.S. Holders Making a Timely QEF Election

 

If a U.S. Holder of our Common Shares makes a timely QEF election (an “Electing Holder”) the Electing Holder must report each year for U.S. federal income tax purposes his pro rata share of our ordinary earnings and our net capital gain, if any, for our taxable year that ends with or within the taxable year of the Electing Holder, regardless of whether or not the Electing Holder actually received distributions from us. (If we did not have any ordinary earnings or net capital gain for a taxable year, then the Electing Holder would have no income or gain to report for that year.) When an Electing Holder makes a QEF election, his adjusted tax basis in our Common Shares is increased to reflect taxed but undistributed earnings and profits. Distributions of earnings and profits that had been previously taxed will result in a corresponding reduction in the adjusted tax basis in our Common Shares and will not be taxed again once distributed. An Electing Holder would generally recognize capital gain or loss on the sale, exchange or other disposition of our Common Shares (including the Pre-Funded Warrants and the Warrants).

 

As noted above, U.S. Holders of our Pre-Funded Warrants should be able to make a QEF election with respect to those Pre-Funded Warrants (assuming that the Pre-Funded Warrants are treated as Common Shares). However, nothing in the Code or Treasury Regulations (including Proposed Regulations) permits U.S. Holders of our Warrants to make a QEF election and, while the issue is not free from doubt, such U.S. Holders should not expect to be able to do so

 

A U.S. Holder eligible to make a QEF election with respect to any year that we are a PFIC does so by filing IRS Form 8621 with his U.S. federal income tax return. This election must be made by the deadline (including extensions) for filing the U.S. Holder’s federal tax return for the year in question. A U.S. Holder who fails to make a timely election can request relief from the IRS to make a late election (but such requests are normally granted only under unusual circumstances). A U.S. Holder who does not make a timely QEF for the first year for which we are a PFIC can make a QEF election for a later year, but if he does so then he will also need to make a “purging election”. In a purging election, the U.S. Holder agrees to treat his PFIC stock as having been sold on the day that he makes the QEF election, and he recognizes the gain, if any, that arises on the deemed sale. U.S. Holders should discuss their election alternatives with their own tax advisors. Once an election is made, the Electing Holder is subject to the QEF rules for as long as we are a PFIC.

 

In order to make a QEF election a U.S. Holder needs information from us concerning our financial results for the year. After the end of each taxable year, we will endeavor to determine whether we were a PFIC for such taxable year, but we are under no obligation to do so. If we determine or otherwise become aware that we are a PFIC for any taxable year, we will endeavor to provide each U.S. Holder with all necessary information (including a PFIC annual information statement) in order to allow such holder to make a QEF election for such taxable year, but, again, we are under no obligation to do so.

 

Taxation of U.S. Holders Making a “Mark-to-Market” Election

 

As an alternative to making a QEF election, a U.S. Holder of our Common Shares may make a “mark-to-market” election with respect to our Common Shares, provided that our Common Shares are treated as “marketable stock” under IRS regulations. Stock is treated as “marketable stock” if it is traded on one or more “qualified” exchanges or other markets on at least 15 days during each calendar quarter (other than in de minimus amounts). A “qualified exchange” includes “a national securities exchange that is registered with the Securities and Exchange Commission or the national market system established pursuant to section 11A of the Securities Exchange Act of 1934.” We believe that our Common Shares (but not our Warrants) will be marketable stock during 2020 and beyond and so a U.S. Holder should be able to make a mark-to-market election with respect to our Common Shares for 2020 and beyond if he so desires. However, we cannot be certain that our Common Shares will be marketable stock during 2020 or subsequent years and so the mark-to-market election may not be available to U.S. Holders for some or all of such years.

 

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A U.S. Holder desiring to make a mark-to-market election must filed Form 8621 in accordance with the relevant instructions and related Treasury regulations.

 

If the mark-to-market election is made, the U.S. Holder generally would include as ordinary income in each taxable year the excess, if any, of the fair market value of the Common Shares at the end of the taxable year over such holder’s adjusted tax basis in our Common Shares. The U.S. Holder would also be permitted an ordinary loss in respect of the excess, if any, of the U.S. Holder’s adjusted tax basis in the our Common Shares over their fair market value at the end of the taxable year, but only to the extent of the net amount of mark-to-market income previously included in income as a result of the mark-to-market election. A U.S. Holder’s tax basis in his Common Shares would be adjusted to reflect any such income or loss amount. Gain realized on the sale, exchange or other disposition of our Common Shares would be treated as ordinary income, and any loss realized on the sale, exchange or other disposition of the Common Shares would be treated as ordinary loss to the extent that such loss does not exceed the net mark-to-market gains previously included by the U.S. Holder.

 

U.S. Holders should be aware that, if our Common Shares do not qualify as marketable stock in future years, they will not be able to make the mark-to-market election in future years and will be taxed in those years under the rules that apply to Non-Electing Holders, as described above, unless they make a QEF election with respect to such years. Accordingly, the options available to U.S. Holders may change over the years and U.S. Holders should continue to consult their tax advisors about their alternatives.

 

While the Code and Treasury Regulations are not free from doubt, the foregoing rules on mark-to-market elections should apply to Pre-Funded Warrants and to Warrants (assuming that the Common Shares qualify as marketable stock).

 

U.S. Holders should also be aware that a foreign company that becomes a PFIC while a U.S. shareholder owns stock in the company remains a PFIC with respect to that shareholder for as long as the shareholder holds the stock (even if the company is at some point no longer classified as a PFIC), unless the shareholder had made an appropriate election or makes a purging election. Accordingly, even though our PFIC status may have no immediate impact on a U.S. Holder’s U.S. tax liability (because we do not plan to make any distributions during 2020 and because we do not expect to have any net earnings or capital gains), the U.S. Holder’s future tax liability as a shareholder in our company may be affected by elections that the U.S. Holder makes today. For this reason, it is important for U.S. Holders to consult their own tax advisors.

 

Non-PFIC status.

 

If we are not classified as a PFIC or, with respect to U.S. Holders who have made an election, we cease to be classified as a PFIC, then the tax consequences of being a U.S. Holder in the company are or will be as follow. The following tax consequences will also apply to a U.S. Holder who did not make a qualifying election but who makes a purging election after we are no longer classified as a PFIC.

 

Taxation of Cash Distributions

 

Subject to the passive foreign investment company, or PFIC, rules discussed above, a U.S. Holder generally will be required to include in gross income as ordinary income the amount of any cash dividend paid in respect of our securities. A cash distribution on our securities generally will be treated as a dividend for U.S. federal income tax purposes to the extent the distribution is paid out of our current or accumulated earnings and profits (as determined for U.S. federal income tax purposes). The portion of such cash distribution, if any, in excess of such earnings and profits will be applied against and reduce (but not below zero) the U.S. Holder’s adjusted tax basis in the securities. Any remaining excess generally will be treated as gain from the sale or other taxable disposition of such securities.

 

The amount of any distribution, and thus potentially of any dividend, will include any amounts withheld by us in respect of Canadian taxes. The U.S. dollar amount of any dividend will not be eligible for the dividends-received deduction generally available to U.S. corporations under the Code. Dividends will be included in a U.S. Holder’s income on the date of the U.S. Holder’s receipt of the dividend. The amount of any dividend income paid in Canadian dollars will be the U.S. dollar amount calculated by reference to the exchange rate in effect on the date of receipt, regardless of whether the payment is in fact converted into U.S. dollars. If the dividend is converted into U.S. dollars on the date of receipt, a U.S. Holder should not be required to recognize foreign currency gain or loss in respect of the dividend income. A U.S. Holder may have foreign currency gain or loss if the dividend is converted into U.S. dollars after the date of receipt.

 

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Dividends paid to a U.S. Holder with respect to our securities generally will be foreign source income, which may be relevant in calculating such U.S. Holder’s foreign tax credit limitations. Subject to applicable limitations, some of which vary depending upon the U.S. Holder’s circumstances, Canadian income taxes withheld from dividends on securities at a rate not exceeding the rate provided by the United States-Canada Income Tax Treaty may be creditable against the U.S. Holder’s U.S. federal income tax liability. The limitation on foreign taxes eligible for credit is calculated separately with respect to specific classes of income. For this purpose, dividends that we distribute generally should constitute “passive category income,” or, in the case of certain U.S. Holders, “general category income.” A foreign tax credit for foreign taxes imposed on distributions may be denied if a U.S. Holder does not satisfy certain minimum holding period requirements. The rules governing foreign tax credits are complex, and U.S. Holders should consult their tax advisers regarding the creditability of foreign taxes in their particular circumstances. In lieu of claiming a foreign tax credit, U.S. Holders may, at their election, deduct foreign taxes, including any Canadian withholding tax imposed on distributions, in computing their taxable income, subject to generally applicable limitations under U.S. law. An election to deduct foreign taxes instead of claiming foreign tax credits applies to all foreign taxes paid or accrued in the taxable year.

 

With respect to non-corporate U.S. Holders, any such cash dividends may be subject to U.S. federal income tax at the lower applicable regular long term capital gains tax rate (see “- Taxation on the Disposition of Common Shares, Warrants or Pre-Funded Warrants” below) provided that (a) our Common Shares are readily tradable on an established securities market in the United States or we are otherwise eligible for the benefits of the United States-Canada Income Tax Treaty, (b) we are not a PFIC, as discussed above, for either the taxable year in which the dividend was paid or the preceding taxable year, and (c) certain holding period requirements are met. On the other hand, if our Common Shares are not readily tradable on an established securities market, and we are not otherwise eligible for the benefits of the United States-Canada Income Tax Treaty, then cash dividends paid by us to non-corporate U.S. Holders with respect to our securities will be subject to U.S. federal income tax at ordinary income tax rates, and not the lower regular long term capital gains tax rate. Under published IRS authority, shares are considered for purposes of clause (a) above to be readily tradable on an established securities market in the United States only if they are listed on certain exchanges, which presently include Nasdaq. U.S. Holders should consult their own tax advisors regarding the availability of the lower rate for any cash dividends paid with respect to our securities.

 

Adjustments with Respect to Warrants

 

The terms of the Warrants and Pre-Funded Warrants provide for an adjustment to the number of Common Shares for which the warrant may be exercised or to the exercise price of the warrant in certain events. An adjustment that has the effect of preventing dilution generally is not taxable. However, the U.S. Holders of the Warrants or Pre-Funded Warrants would be treated as receiving a constructive distribution from us if the adjustment increased the warrant holders’ proportionate interest in our assets or earnings and profits (e.g., through a decrease in the exercise price of the Warrants or Pre-Funded Warrants). Such constructive distribution would be subject to tax as described under “Taxation of Cash Distributions”, above in the same manner as if the U.S. Holders of the Warrants or Pre-Funded Warrants received a cash distribution from us equal to the fair market value of such increased interest.

 

Taxation on the Disposition of Common Shares, Warrants or Pre-Funded Warrants

 

Upon a sale or other taxable disposition of our securities, and subject to the PFIC rules discussed above, a U.S. Holder generally will recognize capital gain or loss in an amount equal to the difference between the amount realized and the U.S. Holder’s adjusted tax basis in the securities.

 

The regular U.S. federal income tax rate on capital gains recognized by U.S. Holders generally is the same as the regular U.S. federal income tax rate on ordinary income, except that long term capital gains recognized by non-corporate U.S. Holders generally are subject to U.S. federal income tax at a maximum regular rate of 20%. Capital gain or loss will constitute long term capital gain or loss if the U.S. Holder’s holding period for the securities exceeds one year. The deductibility of capital losses is subject to various limitations. Any such gain or loss that a U.S. Holder recognizes generally will be treated as U.S. source income or loss for foreign tax credit limitation purposes.

 

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Additional Taxes

 

U.S. Holders that are individuals, estates or trusts and whose income exceeds certain thresholds generally may be subject to a 3.8% Medicare contribution tax on unearned income, including, without limitation, dividends on, and gains from the sale or other taxable disposition of, our securities, subject to certain limitations and exceptions. U.S. Holders should consult their own tax advisors regarding the effect, if any, of such tax on their ownership and disposition of our securities.

 

Exercise or Lapse of a Warrant

 

Subject to the PFIC rules discussed above, a U.S. Holder generally will not recognize gain or loss upon the exercise of a Warrant or Pre-Funded Warrant for cash. A Common Share acquired pursuant to the exercise of a Warrant or Pre-Funded Warrant for cash generally will have a tax basis equal to the U.S. Holder’s tax basis in the Warrant or Pre-Funded Warrant, increased by the amount paid to exercise the Warrant or Pre-Funded Warrant. The holding period of such Common Share generally would begin on the day after the date of exercise of the Warrant. If a Warrant is allowed to lapse unexercised, a U.S. Holder generally will recognize a capital loss equal to such holder’s tax basis in the Warrant.

 

The tax consequences of a cashless exercise of warrants are unclear and could differ from the consequences described above. It is possible that a cashless exercise could be a taxable event. U.S. Holders should consult their own tax advisors regarding the U.S. federal income tax consequences of the cashless exercise of warrants, including with respect to whether the exercise is a taxable event, and their holding period and tax basis in the Common Shares received.

 

Information Reporting and Backup Withholding

 

In general, information reporting for U.S. federal income tax purposes should apply to distributions made on our securities within the United States to a U.S. Holder (other than an exempt recipient) and to the proceeds from sales and other dispositions of our securities by a U.S. Holder (other than an exempt recipient) to or through a U.S. office of a broker. Payments made (and sales and other dispositions effected at an office) outside the United States will be subject to information reporting in limited circumstances. In addition, certain information concerning a U.S. Holder’s adjusted tax basis in securities it owns and adjustments to that tax basis and whether any gain or loss with respect to such securities is long term or short term also may be required to be reported to the IRS.

 

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In addition, U.S. federal income tax information reporting rules generally require certain individuals who are U.S. Holders to file Form 8938 to report the ownership of specified foreign financial assets if the total value of those assets exceeds an applicable threshold amount (subject to certain exceptions). For these purposes, a specified foreign financial asset includes not only a financial account (as defined for these purposes) maintained by a foreign financial institution, but also any stock or security issued by a non-U.S. person, any financial instrument or contract held for investment that has an issuer or counterparty other than a U.S. person and any interest in a foreign entity, provided that the asset is not held in an account maintained by a financial institution. The minimum applicable threshold amount is generally U.S. $50,000 in the aggregate, but this threshold amount varies depending on whether the individual lives in the U.S., is married, files a joint income tax return with his or her spouse, and on certain other factors. Certain domestic entities that are U.S. Holders may also be required to file Form 8938 if both (i) such entities are owned at least 80% by an individual who is a U.S. citizen or U.S. tax resident (or in some cases, by a nonresident alien who meets certain criteria) or are trusts with beneficiaries that are such individuals and (ii) more than 50% of their income consists of certain passive income or more than 50% of their assets is held for the production of such income. U.S. Holders are urged to consult with their tax advisors regarding their reporting obligations, including the requirement to file IRS Form 8938.

 

U.S. Holders who transfer more than $100,000 to us in a 12-month period (and/or who become owners of 10% or more of our securities) will be required to file IRS Form 926, Return by U.S. Transferor of Property to a Foreign Corporation, and U.S. Holders who become holder of more than 10% of our securities may also have to file IRS Form 5471, Information Return of U.S. Persons With Respect to Certain Foreign Corporations, in each case reporting transfers of cash or other property to us and information relating to the U.S. Holder and us. Substantial penalties may be imposed upon a U.S. Holder that fails to comply with these filing requirements. U.S. Holders should consult their own tax advisors about the need to file either of these forms. See also the discussion, above, regarding Form 8621, Information Return by a Shareholder of a Passive Foreign Investment Company or Qualified Electing Fund.

 

Backup withholding of U.S. federal income tax, currently at a rate of 24%, generally will apply to dividends paid on our securities to a U.S. Holder (other than an exempt recipient) and the proceeds from sales and other dispositions of our securities by a U.S. Holder (other than an exempt recipient), in each case who:

 

  fails to provide an accurate taxpayer identification number;
     
  is notified by the IRS that backup withholding is required; or
     
  in certain circumstances, fails to comply with applicable certification requirements.

 

Backup withholding is not an additional tax. Rather, the amount of any backup withholding will be allowed as a credit against a U.S. Holder’s U.S. federal income tax liability and may entitle such holder to a refund, provided that certain required information is timely furnished to the IRS.

 

Holders are urged to consult their own tax advisors regarding the application of backup withholding and the availability of and procedures for obtaining an exemption from backup withholding in their particular circumstances.

 

Non-U.S. Holders

 

Tax Consequences for Non-U.S. Holders of our securities are as follows:

 

Except as provided below, an individual, corporation, estate or trust that is not a U.S. Holder, referred to below as a non-U.S. Holder, generally will not be subject to U.S. federal income or withholding tax on the payment of dividends on, and the proceeds from the disposition of, our securities.

 

A non-U.S. Holder may be subject to U.S. federal income tax on a dividend paid on our securities or gain from the disposition of our securities if: (1) such item is effectively connected with the conduct by the non-U.S. Holder of a trade or business in the United States and, if required by an applicable income tax treaty is attributable to a permanent establishment or fixed place of business in the United States; or (2) in the case of a disposition of our securities, the individual non-U.S. Holder is present in the United States for 183 days or more in the taxable year of the disposition and other specified conditions are met.

 

In general, non-U.S. Holders will not be subject to backup withholding with respect to the payment of dividends on our securities if payment is made through a paying agent, or office of a foreign broker, outside the United States. However, if payment is made in the United States or by a U.S. related person, non-U.S. Holders may be subject to backup withholding, unless the non-U.S. Holder provides an applicable IRS Form W-8 (or a substantially similar form) certifying its foreign status, or otherwise establishes an exemption.

 

The amount of any backup withholding from a payment to a non-U.S. Holder will be allowed as a credit against such holder’s U.S. federal income tax liability and may entitle such holder to a refund, provided that the required information is timely furnished to the IRS.

 

The foregoing description is not intended to constitute a complete analysis of all tax consequences relating to our securities. You should consult your own tax advisor concerning the tax consequences of your particular situation, as well as any tax consequences that may arise under the laws of any state, local, foreign or other taxing jurisdiction.

 

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UNDERWRITING

 

ThinkEquity, a division of Fordham Financial Management, Inc. is acting as representative of the underwriters of the offering. We have entered into an underwriting agreement dated          , 2020 with the representative. Subject to the terms and conditions of the underwriting agreement, we have agreed to sell to each underwriter named below, and each underwriter named below has severally and not jointly agreed to purchase from us, at the public offering price less the underwriting discounts and commissions set forth on the cover page of this prospectus, the number of Common Units and Pre-funded Units listed next to its name in the following table:

 

Underwriter  

Number of
Common Units

 

Number of
Pre-funded Units

ThinkEquity, a division of Fordham Financial Management, Inc.       -
Total        

 

The underwriters are offering the units subject to their acceptance of the units from us and subject to prior sale. The underwriting agreement provides that the obligations of the several underwriters to pay for and accept delivery of the units offered by this prospectus are subject to the approval of certain legal matters by their legal counsel and to certain other conditions. The underwriters are obligated, severally and not jointly, to take and pay for all of the units offered by this prospectus if any such units are taken, other than the units covered by the over-allotment option to purchase additional common shares and/or Warrants described below. The underwriting agreement also provides that if an underwriter defaults, the purchase commitments of non-defaulting underwriters may be increased or this offering may be terminated.

 

The underwriters propose to offer the units to the public at the public offering prices set forth on the cover page of this prospectus. In addition, the underwriters may offer some of the units to other securities dealers at the public offering price less a concession not in excess of US$ ♦ per Common Unit and US$ ♦ per Pre-funded Unit.

 

Over-Allotment Option

 

We have granted the underwriters an over-allotment option. This option, which is exercisable for up to 45 days after the date of this prospectus, permits the underwriters to purchase up to an aggregate of up to additional common shares and/or Pre-Funded Warrants, representing 15% of the common shares and Pre-Funded Warrants sold in the offering and/or up to additional Warrants, representing 15% of the Warrants sold in the offering. The purchase price to be paid per additional share of common shares shall be equal to the public offering price of one Common Unit, less the underwriting discount, the purchase price to be paid per Pre-funded Warrant shall be equal to the public offering price of one Pre-funded Unit, and the purchase price to be paid per additional Warrant shall be US$0.00001. If this option is exercised in full, the total price to the public will be $[  ] and the total net proceeds, before expenses, to us will be US$[  ].

 

Discounts, Commissions and Expenses

 

The following table shows the public offering price, underwriting discounts and commissions and proceeds, before expenses, to us. The information assumes either no exercise or full exercise by the underwriters of their over-allotment option.

 

   Per Unit  

Per Pre-

funded Unit

   Total with no Over-Allotment     Total with Over-Allotment 
Public offering price  US$        US$           US$                  US$                
Underwriting discounts and commissions (7.0%)  US$    US$    US$        US$  
Proceeds, before expenses, to us  US$    US$    US$    US$  

 

We have agreed to pay a non-accountable expense allowance equal to 1.0% of the public offering price payable to the underwriters. We have also agreed to pay certain expenses of the representative in connection with this offering, including: (a) all filing fees and communication expenses associated with the review of this offering by the Financial Industry Regulatory Authority, Inc. (“FINRA”); (b) fees, expenses and disbursements relating to background checks of our officers and directors, in an amount not to exceed US$15,000; (c) fees, expenses and disbursements relating to the registration, qualification or exemption of securities offered under the securities laws of such states and foreign jurisdictions designated by the representative; (d) fees and expenses of the representative’s legal counsel; not to exceed US$125,000 (e) US$29,500 for fees and expenses for the underwriters’ use of book-building, prospectus tracking and compliance software for this offering ; (g) fees and expenses for data services and communications expenses; (f) the costs associated with bound volumes of the public offering materials as well as commemorative mementos and lucite tombstones, each of which the Company or its designee will provide within a reasonable time after the closing in such quantities as the representative may reasonably request, in an amount not to exceed US$3,000; and (g) up to US$15,000 of the representative’s actual accountable road show expenses for the offering.

 

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We estimate that the total expenses of the offering payable by us, not including underwriting discounts and commissions and non-accountable expense allowance, will be approximately US$740,000.

 

Underwriters’ Warrants

 

Upon closing of this offering, we have agreed to issue to the representative or its designees compensation warrants to purchase a number of common shares equal to 5% of the aggregate number of common shares and Pre-funded Warrants sold in this offering (including the over-allotment option). The underwriters’ warrants will be exercisable at a per share exercise price equal to 125% of the public offering price per Common Unit sold in this offering. The underwriters’ warrants are exercisable at any time and from time to time, in whole or in part, during the four and one-half year period commencing six months following the effective date of the registration statement related to this offering. We have registered the warrants and common shares issuable upon the exercise of the underwriters’ warrants in the registration statement of which this prospectus is a part.

 

The underwriters’ warrants and common shares issuable upon the exercise of the underwriters’ warrants, have been deemed compensation by the Financial Industry Regulatory Authority, or FINRA, and are therefore subject to a 180-day lock-up pursuant to Rule 5110(g)(1) of FINRA. The representative, or permitted assignees under such rule, may not sell, transfer, assign, pledge, or hypothecate the underwriters’ warrants or the common shares underlying the underwriters’ warrants, nor will they engage in any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the underwriters’ warrants or the underlying common shares for a period of 180 days from the effective date of the registration statement.

 

Right of First Refusal

 

Until eighteen months from the closing date of this offering, the representative will have, subject to certain exceptions, an irrevocable right of first refusal to act as sole investment banker, sole book-runner and/or sole placement agent, at the representative’s discretion, for each and every future U.S. public and private equity and debt offering, including all equity linked financings, during such eighteen month period for us, or any successor to or any subsidiary of us, on terms customary for the representative. The representative will have the sole right to determine whether or not any other broker-dealer shall have the right to participate in any such offering and the economic terms of any such participation. We also granted the representative a right of first refusal, for a period of eighteen months from the consummation of this offering, to act as the Company’s exclusive financial advisor, if the Company retains a financial advisor, in connection with (a) the acquisition or disposition of business units or assets, (b) the acquisition of any of its outstanding securities, (c) an exchange or tender offer, or (d) a merger, consolidation or other business combination or any recapitalization, reorganization, restructuring or other similar transaction, including, without limitation, an extraordinary dividend or distributions or a spin-off or split-off.

 

Lock-Up Agreements

 

Each of our directors and officers have agreed for a period of six months after the date of this prospectus, and we have agreed for a period of at least three months after the date of this prospectus, without the prior written consent of the representative, not to directly or indirectly (subject to limited exceptions):

 

  issue (in the case of us), offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, lend or otherwise transfer or dispose of, directly or indirectly, any shares of our capital stock, including, but not limited to our common shares and warrants, or any securities convertible into or exercisable or exchangeable for shares of our capital stock; or
     
  file or cause the filing of any registration statement under the Securities Act with respect to any shares of our capital stock, including, but not limited to our common shares and warrants, or any securities convertible into or exercisable or exchangeable for shares of our capital stock; or
     
  in the case of us, complete any offering of our debt securities, other than entering into a line of credit with a traditional bank; or
     
  enter into any swap or other agreement, arrangement, hedge or derivatives transaction that transfers to another, in whole or in part, directly or indirectly, any of the economic consequences of ownership of our common shares or warrants or other capital stock or any securities convertible into or exercisable or exchangeable for our common shares or other capital stock, whether any transaction described in any of the foregoing bullet points is to be settled by delivery of our common shares, warrants or other capital stock, other securities, in cash or otherwise, or publicly announce an intention to do any of the foregoing.

 

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Stabilization

 

In connection with this offering, the underwriters may purchase and sell our common shares or Warrants in the open market. These transactions may include short sales in accordance with Regulation M under the Exchange Act, stabilizing transactions and purchases to cover positions created by short sales. Short sales involve the sale by the underwriters of a greater number of common shares or Warrants than they are required to purchase in this offering. “Covered” short sales are sales made in an amount not greater than the underwriters’ option to purchase additional common shares or Warrants in this offering.

 

The underwriters may close out any covered short position by either exercising their over-allotment option to purchase additional common shares or Warrants or purchasing common share or Warrants in the open market. In determining the source of common shares or Warrants to close out the covered short position, the underwriters will consider, among other things, the price of common shares or Warrants available for purchase in the open market as compared to the price at which they may purchase additional common shares or Warrants pursuant to the option granted to them. “Naked” short sales are any sales in excess of such option. The underwriters must close out any naked short position by purchasing common shares or Warrants in the open market. A naked short position is more likely to be created if the underwriters are concerned that there may be downward pressure on the price of the common shares or Warrants in the open market after pricing that could adversely affect investors who purchase in this offering. Stabilizing transactions consist of various bids for, or purchases of, common shares or Warrants made by the underwriters in the open market prior to the completion of this offering.

 

The underwriters may also impose a penalty bid. This occurs when a particular underwriter repays to the underwriters a portion of the underwriting discount received by it because the representatives have repurchased common shares or Warrants sold by, or for the account of, such underwriter in stabilizing or short covering transactions.

 

Purchases to cover a short position and stabilizing transactions, as well as other purchases by the underwriters for their own accounts, may have the effect of preventing or retarding a decline in the market price of the common shares or Warrants, and together with the imposition of the penalty bid, may stabilize, maintain or otherwise affect the market price of the common shares or Warrants. As a result, the price of the common shares or Warrants may be higher than the price that otherwise might exist in the open market. If these activities are commenced, they are required to be conducted in accordance with applicable laws and regulations, and they may be discontinued at any time. These transactions may be effected on the Nasdaq, the over-the-counter market or otherwise.

 

Passive Market Making

 

In connection with this offering, underwriters and selling group members may engage in passive market making transactions in our common shares or Warrants on the Nasdaq Capital Market in accordance with Rule 103 of Regulation M under the Exchange Act, during a period before the commencement of offers or sales of the shares or Warrants and extending through the completion of the distribution. A passive market maker must display its bid at a price not in excess of the highest independent bid of that security. However, if all independent bids are lowered below the passive market maker’s bid, then that bid must then be lowered when specified purchase limits are exceeded.

 

Indemnification

 

We have agreed to indemnify the underwriters against liabilities relating to this offering arising under the Securities Act and the Exchange Act, liabilities arising from breaches of some or all of the representations and warranties contained in the underwriting agreement, and to contribute to payments that the underwriters may be required to make for these liabilities.

 

Discretionary Accounts

 

The underwriters do not intend to confirm sales of the securities offered hereby to any accounts over which they have discretionary authority.

 

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Listing

 

Our common shares are currently quoted on the OTCQB marketplace under the symbol “BCTXF” and listed on the TSX Venture Exchange under the symbol “BCT” and on the Frankfurt Stock Exchange under the symbol “8BTA”.

 

We have applied to list our common shares and the Warrants included within the units on the Nasdaq Capital Market under the symbols “BCTX” and “BCTXW” respectively. No assurance can be given that such listings will be approved or that a trading market will develop for common shares and Warrants. We have not applied to list the Pre-funded Warrants on any exchange or marketplace.

 

Electronic Offer, Sale and Distribution of Securities

 

A prospectus in electronic format may be made available on the websites maintained by one or more of the underwriters or selling group members. The representative may agree to allocate a number of securities to underwriters and selling group members for sale to its online brokerage account holders. Internet distributions will be allocated by the underwriters and selling group members that will make internet distributions on the same basis as other allocations. Other than the prospectus in electronic format, the information on these websites is not part of, nor incorporated by reference into, this prospectus or the registration statement of which this prospectus forms a part, has not been approved or endorsed by us, and should not be relied upon by investors.

 

Other Relationships

 

From time to time, certain of the underwriters and/or their affiliates have provided, and may in the future provide, various investment banking and other financial services for us for which services they have received and, may in the future receive, customary fees. In the course of their businesses, the underwriters and their affiliates may actively trade our securities or loans for their own account or for the accounts of customers, and, accordingly, the underwriters and their affiliates may at any time hold long or short positions in such securities or loans.

 

On November 16, 2020, the Company completed a brokered private placement of an unsecured convertible debenture unit to a single subscriber, purchased at a price of C$375,000, less an original discount of approximately 29.33%, for aggregate gross proceeds of C$265,000. The representative received a cash commission of C$26,500 and 4,890 non-transferable compensation warrants, exercisable at a price of C$5.42 at any time in whole or in part for a period of five (5) years from the date of issue. The compensation warrants have been deemed compensation by FINRA, and are therefore subject to a 180-day lock-up pursuant to Rule 5110(e)(1) of FINRA. Assuming the offering under the underwriting agreement is completed, the representative, or permitted assignees under such rule, may not sell, transfer, assign, pledge, or hypothecate the compensation warrants or the common shares underlying the compensation warrants, nor will they engage in any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the compensation warrants or the underlying common shares for a period of 180 days from the effective date of the registration statement.

 

Offer restrictions outside the United States

 

Other than in the United States, no action has been taken by us or the underwriters that would permit a public offering of the securities offered by this prospectus in any jurisdiction where action for that purpose is required. The securities offered by this prospectus may not be offered or sold, directly or indirectly, nor may this prospectus or any other offering material or advertisements in connection with the offer and sale of any such securities be distributed or published in any jurisdiction, except under circumstances that will result in compliance with the applicable rules and regulations of that jurisdiction. Persons into whose possession this prospectus comes are advised to inform themselves about and to observe any restrictions relating to the offering and the distribution of this prospectus. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities offered by this prospectus in any jurisdiction in which such an offer or a solicitation is unlawful.

 

Australia

 

This prospectus is not a disclosure document under Chapter 6D of the Australian Corporations Act, has not been lodged with the Australian Securities and Investments Commission and does not purport to include the information required of a disclosure document under Chapter 6D of the Australian Corporations Act. Accordingly, (i) the offer of the securities under this prospectus is only made to persons to whom it is lawful to offer the securities without disclosure under Chapter 6D of the Australian Corporations Act under one or more exemptions set out in section 708 of the Australian Corporations Act, (ii) this prospectus is made available in Australia only to those persons as set forth in clause (i) above, and (iii) the offeree must be sent a notice stating in substance that by accepting this offer, the offeree represents that the offeree is such a person as set forth in clause (i) above, and, unless permitted under the Australian Corporations Act, agrees not to sell or offer for sale within Australia any of the securities sold to the offeree within 12 months after its transfer to the offeree under this prospectus.

 

China

 

The information in this document does not constitute a public offer of the securities, whether by way of sale or subscription, in the People’s Republic of China (excluding, for purposes of this paragraph, Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan). The securities may not be offered or sold directly or indirectly in the PRC to legal or natural persons other than directly to “qualified domestic institutional investors.”

 

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European Economic Area—Belgium, Germany, Luxembourg and Netherlands

 

The information in this document has been prepared on the basis that all offers of securities will be made pursuant to an exemption under the Directive 2003/71/EC (“Prospectus Directive”), as implemented in Member States of the European Economic Area (each, a “Relevant Member State”), from the requirement to produce a prospectus for offers of securities.

 

An offer to the public of securities has not been made, and may not be made, in a Relevant Member State except pursuant to one of the following exemptions under the Prospectus Directive as implemented in that Relevant Member State:

 

  to legal entities that are authorized or regulated to operate in the financial markets or, if not so authorized or regulated, whose corporate purpose is solely to invest in securities;
  to any legal entity that has two or more of (i) an average of at least 250 employees during its last fiscal year; (ii) a total balance sheet of more than €43,000,000 (as shown on its last annual unconsolidated or consolidated financial statements) and (iii) an annual net turnover of more than €50,000,000 (as shown on its last annual unconsolidated or consolidated financial statements);
  to fewer than 100 natural or legal persons (other than qualified investors within the meaning of Article 2(1)(e) of the Prospectus Directive) subject to obtaining the prior consent of the Company or any underwriter for any such offer; or
  in any other circumstances falling within Article 3(2) of the Prospectus Directive, provided that no such offer of securities shall result in a requirement for the publication by the Company of a prospectus pursuant to Article 3 of the Prospectus Directive.

 

France

 

This document is not being distributed in the context of a public offering of financial securities (offre au public de titres financiers) in France within the meaning of Article L.411-1 of the French Monetary and Financial Code (Code Monétaire et Financier) and Articles 211-1 et seq. of the General Regulation of the French Autorité des marchés financiers (“AMF”). The securities have not been offered or sold and will not be offered or sold, directly or indirectly, to the public in France.

 

This document and any other offering material relating to the securities have not been, and will not be, submitted to the AMF for approval in France and, accordingly, may not be distributed or caused to distributed, directly or indirectly, to the public in France.

 

Such offers, sales and distributions have been and shall only be made in France to (i) qualified investors (investisseurs qualifiés) acting for their own account, as defined in and in accordance with Articles L.411-2-II-2° and D.411-1 to D.411-3, D.744-1, D.754-1 ;and D.764-1 of the French Monetary and Financial Code and any implementing regulation and/or (ii) a restricted number of non-qualified investors (cercle restreint d’investisseurs) acting for their own account, as defined in and in accordance with Articles L.411-2-II-2° and D.411-4, D.744-1, D.754-1; and D.764-1 of the French Monetary and Financial Code and any implementing regulation.

 

Pursuant to Article 211-3 of the General Regulation of the AMF, investors in France are informed that the securities cannot be distributed (directly or indirectly) to the public by the investors otherwise than in accordance with Articles L.411-1, L.411-2, L.412-1 and L.621-8 to L.621-8-3 of the French Monetary and Financial Code.

 

Ireland

 

The information in this document does not constitute a prospectus under any Irish laws or regulations and this document has not been filed with or approved by any Irish regulatory authority as the information has not been prepared in the context of a public offering of securities in Ireland within the meaning of the Irish Prospectus (Directive 2003/71/EC) Regulations 2005 (the “Prospectus Regulations”). The securities have not been offered or sold, and will not be offered, sold or delivered directly or indirectly in Ireland by way of a public offering, except to (i) qualified investors as defined in Regulation 2(l) of the Prospectus Regulations and (ii) fewer than 100 natural or legal persons who are not qualified investors.

 

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Israel

 

The securities offered by this prospectus have not been approved or disapproved by the Israeli Securities Authority (the ISA), nor have such securities been registered for sale in Israel. The shares may not be offered or sold, directly or indirectly, to the public in Israel, absent the publication of a prospectus. The ISA has not issued permits, approvals or licenses in connection with the offering or publishing the prospectus; nor has it authenticated the details included herein, confirmed their reliability or completeness, or rendered an opinion as to the quality of the securities being offered. Any resale in Israel, directly or indirectly, to the public of the securities offered by this prospectus is subject to restrictions on transferability and must be effected only in compliance with the Israeli securities laws and regulations.

 

Italy

 

The offering of the securities in the Republic of Italy has not been authorized by the Italian Securities and Exchange Commission (Commissione Nazionale per le Società e la Borsa, or “CONSOB”) pursuant to the Italian securities legislation and, accordingly, no offering material relating to the securities may be distributed in Italy and such securities may not be offered or sold in Italy in a public offer within the meaning of Article 1.1(t) of Legislative Decree No. 58 of 24 February 1998 (“Decree No. 58”), other than:

 

  to Italian qualified investors, as defined in Article 100 of Decree no.58 by reference to Article 34-ter of CONSOB Regulation no. 11971 of 14 May 1999 (“Regulation no. 1197l”) as amended (“Qualified Investors”); and
  in other circumstances that are exempt from the rules on public offer pursuant to Article 100 of Decree No. 58 and Article 34-ter of Regulation No. 11971 as amended.

 

Any offer, sale or delivery of the securities or distribution of any offer document relating to the securities in Italy (excluding placements where a Qualified Investor solicits an offer from the issuer) under the paragraphs above must be:

 

  made by investment firms, banks or financial intermediaries permitted to conduct such activities in Italy in accordance with Legislative Decree No. 385 of 1 September 1993 (as amended), Decree No. 58, CONSOB Regulation No. 16190 of 29 October 2007 and any other applicable laws; and
  in compliance with all relevant Italian securities, tax and exchange controls and any other applicable laws.

 

Any subsequent distribution of the securities in Italy must be made in compliance with the public offer and prospectus requirement rules provided under Decree No. 58 and the Regulation No. 11971 as amended, unless an exception from those rules applies. Failure to comply with such rules may result in the sale of such securities being declared null and void and in the liability of the entity transferring the securities for any damages suffered by the investors.

 

Japan

 

The securities have not been and will not be registered under Article 4, paragraph 1 of the Financial Instruments and Exchange Law of Japan (Law No. 25 of 1948), as amended (the “FIEL”) pursuant to an exemption from the registration requirements applicable to a private placement of securities to Qualified Institutional Investors (as defined in and in accordance with Article 2, paragraph 3 of the FIEL and the regulations promulgated thereunder). Accordingly, the securities may not be offered or sold, directly or indirectly, in Japan or to, or for the benefit of, any resident of Japan other than Qualified Institutional Investors. Any Qualified Institutional Investor who acquires securities may not resell them to any person in Japan that is not a Qualified Institutional Investor, and acquisition by any such person of securities is conditional upon the execution of an agreement to that effect.

 

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Portugal

 

This document is not being distributed in the context of a public offer of financial securities (oferta pública de valores mobiliários) in Portugal, within the meaning of Article 109 of the Portuguese Securities Code (Código dos Valores Mobiliários). The securities have not been offered or sold and will not be offered or sold, directly or indirectly, to the public in Portugal. This document and any other offering material relating to the securities have not been, and will not be, submitted to the Portuguese Securities Market Commission (Comissăo do Mercado de Valores Mobiliários) for approval in Portugal and, accordingly, may not be distributed or caused to distributed, directly or indirectly, to the public in Portugal, other than under circumstances that are deemed not to qualify as a public offer under the Portuguese Securities Code. Such offers, sales and distributions of securities in Portugal are limited to persons who are “qualified investors” (as defined in the Portuguese Securities Code). Only such investors may receive this document and they may not distribute it or the information contained in it to any other person.

 

Sweden

 

This document has not been, and will not be, registered with or approved by Finansinspektionen (the Swedish Financial Supervisory Authority). Accordingly, this document may not be made available, nor may the securities be offered for sale in Sweden, other than under circumstances that are deemed not to require a prospectus under the Swedish Financial Instruments Trading Act (1991:980) (Sw. lag (1991:980) om handel med finansiella instrument). Any offering of securities in Sweden is limited to persons who are “qualified investors” (as defined in the Financial Instruments Trading Act). Only such investors may receive this document and they may not distribute it or the information contained in it to any other person.

 

Switzerland

 

The securities may not be publicly offered in Switzerland and will not be listed on the SIX Swiss Exchange (“SIX”) or on any other stock exchange or regulated trading facility in Switzerland. This document has been prepared without regard to the disclosure standards for issuance prospectuses under art. 652a or art. 1156 of the Swiss Code of Obligations or the disclosure standards for listing prospectuses under art. 27 ff. of the SIX Listing Rules or the listing rules of any other stock exchange or regulated trading facility in Switzerland. Neither this document nor any other offering material relating to the securities may be publicly distributed or otherwise made publicly available in Switzerland.

 

Neither this document nor any other offering material relating to the securities have been or will be filed with or approved by any Swiss regulatory authority. In particular, this document will not be filed with, and the offer of securities will not be supervised by, the Swiss Financial Market Supervisory Authority (FINMA).

 

This document is personal to the recipient only and not for general circulation in Switzerland.

 

United Arab Emirates

 

Neither this document nor the securities have been approved, disapproved or passed on in any way by the Central Bank of the United Arab Emirates or any other governmental authority in the United Arab Emirates, nor has the Company received authorization or licensing from the Central Bank of the United Arab Emirates or any other governmental authority in the United Arab Emirates to market or sell the securities within the United Arab Emirates. This document does not constitute and may not be used for the purpose of an offer or invitation. No services relating to the securities, including the receipt of applications and/or the allotment or redemption of such shares, may be rendered within the United Arab Emirates by the Company.

 

No offer or invitation to subscribe for securities is valid or permitted in the Dubai International Financial Centre.

 

United Kingdom

 

Neither the information in this document nor any other document relating to the offer has been delivered for approval to the Financial Services Authority in the United Kingdom and no prospectus (within the meaning of section 85 of the Financial Services and Markets Act 2000, as amended (“FSMA”) has been published or is intended to be published in respect of the securities. This document is issued on a confidential basis to “qualified investors” (within the meaning of section 86(7) of FSMA) in the United Kingdom, and the securities may not be offered or sold in the United Kingdom by means of this document, any accompanying letter or any other document, except in circumstances which do not require the publication of a prospectus pursuant to section 86(1) FSMA. This document should not be distributed, published or reproduced, in whole or in part, nor may its contents be disclosed by recipients to any other person in the United Kingdom.

 

Any invitation or inducement to engage in investment activity (within the meaning of section 21 of FSMA) received in connection with the issue or sale of the securities has only been communicated or caused to be communicated and will only be communicated or caused to be communicated in the United Kingdom in circumstances in which section 21(1) of FSMA does not apply to the Company.

 

In the United Kingdom, this document is being distributed only to, and is directed at, persons (i) who have professional experience in matters relating to investments falling within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotions) Order 2005 (“FPO”), (ii) who fall within the categories of persons referred to in Article 49(2)(a) to (d) (high net worth companies, unincorporated associations, etc.) of the FPO or (iii) to whom it may otherwise be lawfully communicated (together “relevant persons”). The investments to which this document relates are available only to, and any invitation, offer or agreement to purchase will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.

 

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MATERIAL AGREEMENTS

 

We have not entered into any material agreements other than in the ordinary course of business and other than those described below or in this prospectus.

 

On September 29, 2017, the Company entered into a certain Clinical Study Agreement with Cancer Insight, LLC (the “CRO”), a cancer vaccine-focused contract/clinical research organization, pursuant to which the CRO conducted a phase I/IIA study of BriaVaxTM (a.k.a. Bria-IMT) and provided regulatory affairs management services. As consideration, the Company paid the CRO eight equal quarterly payments of $112,848.14. On October 19, 2018 the parties amended the Clinical Study Agreement to increase the budget by a total of $332,817.66.

 

On October 16, 2017, the Company entered into a certain Service Agreement with Colorado State University (“CSU”), pursuant to which CSU provided certain clinical research services to the Company concerning its PKCδ inhibitors. As consideration, the Company paid CSU a fixed price amount of $191,719. On April 2, 2019, the parties amended the Service Agreement to extend the termination date to March 1, 2020 and increase CSU’s compensation from $191,719 to $219,056.

 

On January 26, 2018, the CRO, Jarrod Holmes, M.D., and St. Joseph Heritage Healthcare (“SJ”), a California nonprofit public benefit corporation, entered into a Clinical Trial Agreement, amended as of May 7, 2019, pursuant to which SJ agreed to participate in conducting the Company’s phase I/IIA study of BriaVaxTM (a.k.a. Bria-IMT).

 

On April 23, 2018, the CRO and the Cancer Center of Kansas, P.A. (“CCK”) entered into a Clinical Trial Agreement, amended as of October 22, 2018, pursuant to which CCK agreed to participate in conducting the Company’s phase I/IIA study of BriaVaxTM (a.k.a. Bria-IMT).

 

On August 27, 2018, the Company entered into an Amendment No. 2 to the University Agreement with the University of California, Davis Health, pursuant to which the termination date of the original University Agreement, dated June 11, 2015, was extended July 1, 2020.

 

On September 4, 2018, the CRO and the University of Miami (“UM”) entered into a Clinical Trial Agreement, pursuant to which UM agreed to participate in conducting the Company’s phase I/IIA study of BriaVaxTM (a.k.a. Bria-IMT).

 

On October 2, 2018, the CRO, Providence Health & Services - Washington, dba Providence Regional Medical Center Everett (“PHS”), the Everett Clinic, PLLC (the “Clinic”) and Jason Lukas, M.D., an employee of the Clinic, entered into a Clinical Trial Agreement, pursuant to which PHS and the Clinic agreed to participate in conducting the Company’s phase I/IIA study of BriaVaxTM (a.k.a. Bria-IMT).

 

On May 3, 2019, the Company entered into that certain UC Davis Stem Cell Program Services Agreement (the “UCD Agreement”) with the University of California, Davis Health (“UCD”), pursuant to which UCD shall provide the Company with certain services related to stem cells and the Company shall pay UCD a total of $35,855. The UCD agreement terminates on May 1, 2021.

 

On June 3, 2019, the Company entered into that certain HLA Typing Services Agreement with HistoGenetics, LLC, a New York limited liability company, effective June 1, 2019, pursuant to which HLA shall provide the Company with certain HLA typing by DNA sequencing services.

 

On June 13, 2019, the Company entered into a certain procurement agreement with Catalent Pharma Solutions, LLC (“Catalent”), pursuant to which Catalent shall procure certain biopharmaceutical products for the Company. As consideration, the Company paid Catalent a total of $442,982.

 

On June 3, 2019, the Company entered into an agreement with Catalent, pursuant to which Catalent shall provide certain clinical supply services to the Company (the “Catalent Supply Agreement”). As consideration, and upon achievement of certain milestones as set forth in the Catalent Supply Agreement, the Company shall pay Catalent up to $149,167. In connection with the Catalent Supply Agreement, on June 25, 2019, the parties entered into that certain Quality Agreement to outline the certain drug delivery and clinical supply services to be provided by Catalent.

 

On September 9, 2019 the Company completed non brokered private placement of 40,300 common shares at a price of $21 per common share for gross proceeds of $846,300.

 

On October 15, 2019, the Company completed non brokered private placement of 27,069 common shares at a price of $21 per common share for gross proceeds of $568,444.

 

On March 25, 2019 and April 1, 2019, the Company completed a non-brokered private placement on of 99,117 shares of the Company at a price of $30 per share for aggregate gross proceeds of $2,973,524 (net proceeds: $2,845,784). Included in the Private Placement were $500,000 from Jamieson Bondarenko, an insider of the Company

 

On February 26, 2019, BriaCell announced a non-brokered private placement financing of 16,667 common shares of the Company to Mr. Bondarenko at a price of $30 per common share for gross proceeds of $500,000. Upon closing of the Offering, Mr. Bondarenko had a beneficial ownership of an aggregate of 76,902 common shares, representing approximately 13.7% of the Company’s issued and outstanding common shares.

 

On March 27, 2018, the Company completed a non-brokered private placement (the “Non-Brokered Unit Offering”) of 144,408 units of the Company (the “Units”) at a price of $30 per Unit for aggregate gross proceeds of $4,332,232. Under the Non-Brokered Unit Offering, each Unit consists of one common share (each, a “March Common Share”) and one common share purchase warrant (each, a “March Warrant”). The March Warrants are valid for 36 months following the closing of the Non-Brokered Unit Offering and each March Warrant is exercisable for one March Common Share at an exercise price of $42.

 

Concurrent with the Non-Brokered Unit Offering, the Company also completed a brokered private placement for the purchase of 5.0% unsecured convertible notes (each, a “March Note”) in the principal amount of US$885,000 (the “March Note Offering”). Under the terms of securities purchase agreements dated March 8, 2018 between the Company and the purchasers of March Notes, each March Note is convertible at the option of the holder into (i) common shares of BriaCell for so long as the March Note is outstanding, at a fixed conversion price of $30 per March Common Share, for a period of nine months from the date of issuance, which may be extended by the applicable holder for up to six additional months at the holder’s sole option, and (ii) for each March Common Share resulting from the conversion, one March Warrant. The March Warrants are valid for 36 months from their issuance date and each March Warrant is exercisable for one March Common Share at an exercise price of $42.

 

In connection with the Non-Brokered Unit Offering and the Note Offering (together, the “March Offerings”), the Company paid commissions to certain participating dealers on a portion of funds raised. In respect of the March Note Offering, an aggregate cash commissions of $235,215 and an aggregate 8,711 broker warrants (the “Broker Warrants”) were paid. The compensation warrants issued in connection with the March Offerings are exercisable for one March Common Share at an exercise price of $42 for a period of 36 months from the issue date.

 

Officers and members of the Company’s board of directors, including BriaCell’s Chief Executive Officer, Chief Financial Officer and the board’s Chairman, participated in the NonBrokered Unit Offering.

 

During July 2018, certain noteholders converted $106,843 of the Notes into 3,561 shares and 3,561 warrants and during August 2018, an additional $117,437 of Notes were converted and as such, the Company issued 3,915 shares and 3,915 warrants. On September 17, 2018, the Company and the Noteholders agreement to extend the repayment date of the Convertible notes for an additional six month, to March 2019.

 

On February 27, 2020, the Company and the CRO entered into a Master Services Agreement, effective February 26, 2020, pursuant to which the CRO shall conduct a phase I/IIA study of BriaVaxTM (a.k.a. Bria-IMT) with the Incyte drugs INCMGA00012 (an anti-PD-1 antibody) and epacadostat, an orally bioavailable small-molecule inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1). As consideration, the Company shall pay CRO twenty-eight equal monthly installment payments of $86,691.78.

 

On April 24, 2020, the Company received a $40,000 loan from the Canada Emergency Business Account (“CEBA Loan”). The CEBA Loan bears 0% interest until December 31, 2022. If the balance is not paid by December 31, 2022, the remaining balance will be converted to a 3-year term loan at 5% annual interest, paid monthly, effective January 1, 2023. The full balance must be repaid by no later than December 31, 2025. No principal payments are required until December 31, 2022. Principal repayments can be voluntarily made at any time without fees or penalties. $10,000 loan forgiveness is available, provided the outstanding balance is $40,000 at December 31, 2020, and $30,000 is paid back between January 1, 2021 and December 31, 2022.

 

On May 1, 2020 the Company received US$127,030 as a loan from the Paycheck Protection Program in the United States (the “Program”). The terms of the Program provide that a portion of the loan may be forgiven, to the extent that the amounts spent during the eight week period following the first disbursement of the loan are incurred as follows: (i) payroll costs, (ii) interest payments on mortgages incurred before February 15, 2020, (iii) rent payments on leases in effect before February 15, 2020, and (iv) utility payments for which service began before February 15, 2020. The unforgiven part of the loan must be repaid within two years and bears interest at 1% per annum.

 

130
 

 

EXPERTS AND LEGAL MATTERS

 

No expert or counsel named in this prospectus as having prepared or certified any part of this prospectus or having given an opinion upon the validity of the securities being registered or upon other legal matters in connection with the registration or offering of the securities was employed on a contingency basis or had, or is to receive, in connection with the offering, a substantial interest, directly or indirectly, in the Company or its subsidiaries. Nor was any such person connected with the Company or any of its subsidiaries as a promoter, managing or principal underwriter, voting trustee, director, officer or employee. Sichenzia Ross Ference LLP has been issued 50,000 restricted common shares stock of the Company as compensation for legal services and these share are being offered pursuant to the Selling Shareholder Prospectus.

 

The financial statements included in this prospectus and elsewhere in the registration statement have been so included in reliance upon the report of MNP LLP, independent registered public accountants, upon the authority of said firm as experts in accounting and auditing.

 

Certain legal matters in connection with this offering will be passed upon for us by Sichenzia Ross Ference LLP, New York, New York. The validity of the issuance of our common shares offered in this prospectus and certain other legal matters as to Canadian law will be passed upon for us by Bennett Jones LLP, Toronto, Canada. The underwriters are being represented by Clark Wilson LLP, Vancouver, BC, Canada.

 

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

 

MNP LLP are our independent auditors. There have not been any disagreements with our auditors on accounting and financial disclosure or any other matter.

 

EXPENSES OF THIS OFFERING

 

The estimated expenses payable by us in connection with the offering described in this prospectus (other than the underwriting discounts and commissions) will be as set forth in the table below. With the exception of the U.S. Securities and Exchange Commission registration fee, the FINRA filing fee, and the Nasdaq Capital Market listing fee, all amounts are estimates. All such expenses will be borne by the Registrant.

 

Item   Amount
to be Paid (USD)
SEC registration fee   US$   4,289.47  
FINRA filing fee   US$   5,287.00  
The Nasdaq Capital Market listing fee   US$   50,000.00  
Printing and engraving expenses   US$   10,000.00  
Legal fees and expenses   US$   375,000.00  
Accounting fees and expenses   US$   50,000.00   
Miscellaneous expenses   US$   247,500.00  
Total   US$   742,076.47  

 

131
 

 

FINANCIAL STATEMENTS

 

 

 

Consolidated Financial Statements

 

For the Years Ended July 31, 2020 and 2019

Expressed in Canadian Dollars

 

 

 

Corporate Office- Canada

Suite 300 - Bellevue Centre

235 -15th Street

West Vancouver, BC V7T 2X1

Tel: 604-921-1810

Fax: 604-921-1898

Corporate Office- US

820 Heinz Avenue

Berkeley, CA, 94710

Tel: 1-888-485-6340

Fax: 424-245-3719

 

 

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and Shareholders of BriaCell Therapeutics Corp.

 

Opinion on the Consolidated Financial Statements

 

We have audited the accompanying consolidated statements of financial position of BriaCell Therapeutics Corp. (the Company) as of July 31, 2020 and 2019, and the related consolidated statements of operations and comprehensive loss, cash flows, and changes in shareholders’ equity for each of the three years ended July 31, 2020, and the related notes (collectively referred to as the consolidated financial statements).

 

In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company as of July 31, 2020 and 2019, and the results of its consolidated operations and its consolidated cash flows for each of the three years ended July 31, 2020 in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.

 

Material Uncertainty Related to Going Concern

 

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has suffered losses from inception and negative operating cash flows that raise substantial doubt about its ability to continue as a going concern. Management’s plans with regards to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Basis for Opinion

 

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

 

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

 

Chartered Professional Accountants

 

Licensed Public Accountants

 

 

We have served as the Company’s auditor since 2015.

 

Mississauga, Canada

 

November 30, 2020

 

 F-1 

 

 

BriaCell Therapeutics Corp

Consolidated Statements of Financial Position
As at July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

    July 31, 2020     July 31, 2019  
ASSETS            
             
Current assets                
Cash   $ 26,104     $ 192,916  
Amounts receivable     27,660       3,459  
Prepaid expenses     267,444       10,667  
Total current assets     321,208       207,042  
                 
Investments     2       2  
Intellectual property (Note 4)     320,474       339,215  
                 
Total Assets   $ 641,684     $ 546,259  
                 
LIABILITIES AND SHAREHOLDERS’ DEFICIT                
                 
Current liabilities                
Accounts payable and accrued liabilities (Note 10)   $ 4,562,856     $ 996,172  
Short term loans (Note 5(a))     306,878       -  
Unsecured convertible loan (Note 6)     -       396,224  
Total current liabilities     4,869,734       1,392,396  
                 
Long term liabilities                
Government Grants (Note 5(b))     191,572       -  
Total long term liabilities     191,572       1,392,396  
                 
Shareholders’ equity                
Share capital (Note 7(b))     15,065,961       13,651,217  
Share-based payment reserve (Note 8)     739,193       877,089  
Warrant reserve (Note 7(c))     2,271,910       2,870,442  
Accumulated other comprehensive loss     (170,374 )     (124,295 )
Deficit     (22,326,312 )     (18,120,590 )
Total shareholders’ deficit     (4,419,622 )     (846,137 )
                 
Total liabilities and shareholders’ deficit   $ 641,684     $ 546,259  

 

Nature of Operations and Going Concern (Note 1)

Commitments (Note 15)

Events After the Reporting Period (Note 16)

These consolidated financial statements were approved and authorized for issue on behalf of the Board of Directors on November 30, 2020 by:

On behalf of the Board:

 

Jamieson Bondarenko   “William Williams”
Director   Director

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 F-2 

 

 

BriaCell Therapeutics Corp

Consolidated Statements of Operations and Comprehensive Loss

For the Years Ended July 31, 2020, 2019 and 2018
(Expressed in Canadian Dollars)

 

    Year ended  
    July 31,  
    2020     2019     2018  
Expenses:                  
Research and development costs (Note 13)   $ 2,980,144     $ 4,917,287     $ 3,112,579  
General and administration costs (Note 14)     1,857,465       1,244,471       1,387,713  
Share-based compensation (Note 8(vi))     2,071       60,586       476,211  
Total Expenses     4,839,680       6,222,344       4,976,503  
                         
Operating Loss     (4,839,680 )     (6,222,344 )     (4,976,503 )
Interest income     -       12,004       15,991  
Interest expense (Note 5,6)     (36,216 )     (31,317 )     (20,364 )
Gain from government grant (Note 5)     28,604       -       -  
Change in fair value of convertible debt (Note 6)     (79,119 )     420,585       (407,709 )
Foreign exchange income (loss)     (17,810 )     31,410       (24,078 )
      (104,541 )     432,682       (436,160 )
                         
Loss For The Year     (4,944,221 )     (5,789,662 )     (5,412,663 )
                         
Items That Will Subsequently Be Reclassified To Profit Or Loss                        
Foreign currency translation adjustment     (46,079 )     (18,781 )     (33,340 )
      (46,079 )     (18,781 )     (33,340 )
                      -  
Comprehensive Loss for the Year   $ (4,990,300 )   $ (5,808,443 )   $ (5,446,003 )
                      -  
Basic and Fully Diluted Loss Per Share   $ (6.99 )   $ (10.02 )   $ (0.04 )
                         
Weighted Average Number Of Shares Outstanding     713,889       579,664       427,815  

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 F-3 

 

 

BriaCell Therapeutics Corp

Consolidated Statements of Cash Flows

For the Years Ended July 31, 2020, 2019 and 2018

(Expressed in Canadian Dollars)

 

    Year ended  
    July 31,  
    2020     2019     2018  
Cash flow from operating activities                        
Net loss for the year     (4,944,221 )   $ (5,789,662 )   $ (5,412,663 )
Items not affecting cash:             -          
Depreciation and amortization     18,741       18,743       16,894  
Share-based compensation     2,071       60,586       476,211  
Accrued interest expense     36,216       -       20,364  
Foreign exchange                        
Gain from government grant     (28,604 )     -       -  
Change in fair value of convertible loan     79,119       (420,585 )     407,709  
Changes in non-cash working capital:                        
Amounts receivable     (24,201 )     15,516       (11,994 )
Prepaid expenses     (256,777 )     137,067       (117,051 )
Security deposits     -       172,980       (151,413 )
Accounts payable and accrued liabilities     3,562,494       710,460       (186,650 )
      (1,555,162 )     (5,094,895 )     (4,958,593 )
                         
Cash flow from investing activities                        
Change in short-term investments     -       1,341,043       (591,043 )
      -       1,341,043       (591,043 )
                         
Cash flow from financing activities                        
Proceeds for private placements     1,414,744       2,973,324       4,332,232  
Short-term loan     505,159       (117,540 )     (465,849 )
Repayment of unsecured convertible loan     (477,559 )     -       1,138,919  
Proceeds from exercise of warrants     -       140,000       286,020  
      1,442,344       2,995,784       5,291,322  
                         
Increase (Decrease) in cash and cash equivalents     (112,818 )     (758,068 )     (258,314 )
Effect of changes in foreign exchange rates     (53,994 )     12,536       (67,667 )
Cash and cash equivalents, beginning of year     192,916       938,448       1,264,429  
                         
Cash and cash equivalents, end of year     26,104     $ 192,916     $ 938,448  

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 F-4 

 

 

BriaCell Therapeutics Corp

Consolidated Statements of Changes in Shareholders’ Equity

For the Years Ended July 31, 2020, 2019 and 2018

(Expressed in Canadian Dollars)

 

    SHARE CAPITAL     SHARE-BASED PAYMENT      WARRANT     ACCUMULATED OTHER COMPREHENSIVE     ACCUMULATED     TOTAL SHAREHOLDERS’ EQUITY  
    SHARES     AMOUNT     RESERVE     RESERVE     LOSS     DEFICIT     (DEFICIT)  
Balance, July 31, 2017     353,015     $ 6,609,615     $ 884,763     $ 1,841,448     $ (72,174 )   $ (8,328,600 )   $ 935,052  
Private Placement (Note 7(b)(i))     13,528       631,785       -       -       -       -       631,785  
Acquisition of Sapientia (Note 7(b)(ii))     8,333       375,000       -       -       -       -       375,000  
Exercise of warrants (Note 7(b)(iii))     6,810       351,557       -       (65,537 )     -       -       286,020  
Private Placement (Note 7(b)(iv))     144,408       2,644,659       -       1,687,573       -       -       4,332,232  
Share issuance costs     -       (465,850 )     -       -       -       -       (465,850 )
Issuance of shares and warrants on conversion of Convertible Notes (Note 7(b)(v))     3,561       66,408       -       40,435       -       -       106,843  
Issuance of warrants on conversion of Convertible Notes     -       -       -       97,875       -       -       97,875  
Expiration of warrants and compensation warrants (Note 7(c)(i), 7(d)(i))     -       -       -       (694,457 )     -       694,457       -  
Share-based compensation (Note 8(i))     -       -       378,336       -       -       -       378,336  
Expiration of options (Note 8(ii))     -       -       (357,842 )     -       -       357,842       -  
Foreign exchange translation     -       -       -       -       (33,340 )     -       (33,340 )
Loss for the year     -       -       -       -       -       (5,412,663 )     (5,412,663 )
Balance, July 31, 2018     529,655       10,213,174       905,257       2,907,337       (105,514 )     (12,688,964 )     1,231,290  
Issuance of shares and warrants on conversion of Convertible Notes (Note 7(b)(vi))     22,488       408,119       -       266,526       -       -       674,645  
Exercise of warrants (Note 7(b)(vii))     3,333       174,140       -       (34,140 )     -       -       140,000  
Private Placement (Note 7(b)(viii))     99,117       2,855,784       -       -       -       -       2,855,784  
Expiration of warrants (Note 7(c)(ii))     -               -       (269,282 )     -       269,282       -  
Expiration of options (Note 8(iii))     -       -       (88,754 )     -       -       88,754       -  
Share-based compensation (Note 8)     -       -       60,586       -       -       -       60,586  
Foreign exchange translation     -       -       -       -       (18,781 )     -       (18,781 )
Loss for the year     -       -       -       -       -       (5,789,662 )     (5,789,662 )
Balance, July 31, 2019     654,593       13,651,217       877,089       2,870,442       (124,295 )     (18,120,590 )     (846,137 )
Private Placement (Note 7(b)(ix))     40,300       846,300       -       -       -       -       846,300  
Private Placement (Note 7(b)(x))     27,069       568,444       -       -       -       -       568,444  
Expiration of warrants (Note 7(c)(iii),(Note 7(d)(ii))     -       -       -       (598,532 )     -       598,532       -  
Expiration of options (Note 8(v))     -       -       (139,967 )     -       -       139,967       -  
Share-based compensation (Note 8(vi))     -       -       2,071       -       -       -       2,071  
Foreign exchange translation     -       -       -       -       (46,079 )     -       (46,079 )
Loss for the year     -       -       -       -       -       (4,944,221 )     (4,944,221 )
                                                         
Balance, July 31, 2020     721,962     $ 15,065,961     $ 739,193       2,271,910     $ (170,374 )   $ (22,326,312 )   $ (4,419,622 )

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 F-5 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

1. Nature of Operations and Going Concern

 

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) was incorporated under the Business Corporations Act (British Columbia) on July 26, 2006 and is listed on the TSX Venture Exchange (“TSX Venture”). The Company trades on the TSX Venture under the symbol “BCT.V”.

 

The Company’s head office is located at Suite 300 – 235 West 15th Street, West Vancouver, British Columbia, V7T 2X1.

 

BriaCell is an immuno-oncology biotechnology company. BriaCell owns the US patent to Bria-IMT™, a whole-cell cancer vaccine (US Patent No.7674456) (the “Patent”). The Company is currently advancing its immunotherapy program, Bria-IMT™, to complete a 24-subject Phase I/IIa clinical trial and by research activities in the context of BriaDx™, a companion diagnostic test to identify patients likely benefitting from Bria-IMT™.

 

The accompanying consolidated financial statements have been prepared on the basis of a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business for the foreseeable future. The Company has incurred losses from inception of $22,326,312 (July 31, 2019 - $18,120,590), and negative cash flows from operations of $1,555,162 (2019- $5,094,895, 2018- $4,958,593) is currently in the development stage and has not commenced commercial operations. The Company’s ability to continue as a going concern is dependent upon its ability to attain future profitable operations and to obtain the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they come due. As at July 31, 2020, the Company had not yet completed the clinical development of or achieved regulatory approval to market Bria-IMT™, its lead product candidate and expects to incur further losses; the nature of a development stage immune-oncology company requires the raising of financial capital to support its clinical development programs and administrative costs. The uncertainty of the Company’s ability to raise such financial capital casts significant doubt on the Company’s ability to continue as a going concern. These consolidated financial statements do not include any adjustments to the amounts and classification of assets and liabilities that might be necessary should the Company not be able to continue as a going concern.

 

These consolidated financial statements were authorized for issue by the Board of Directors on November 30, 2020.

 

 F-6 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

2. Basis of Presentation

 

Statement of Compliance

 

These consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”), as issued by the international Accounting Standards Board (“IASB”) as and interpretations of the IFRS Interpretations Committee (“IFRIC”).

 

The policies applied in these consolidated financial statements are based on IFRS effective as of July 31, 2020.

 

Basis of Presentation

 

The consolidated financial statements are prepared on a going concern basis and have been presented in Canadian dollars which is the Company’s reporting currency. A summary of the significant accounting policies is provided in Note 3. Standards and guidelines not effective for the current accounting period are described in Note 4.

 

Basis of Measurement

 

These consolidated financial statements have been prepared on a going concern basis, under the historical cost basis, except for financial instruments which have been measured at fair value.

 

Basis of Consolidation

 

These consolidated financial statements include the accounts of BriaCell and its wholly-owned US subsidiary BriaCell Therapeutics Corp. (“BTC”) and BTC’s wholly owned subsidiary – Sapientia Pharmaceuticals, Inc. (“Sapientia”). The financial statements of the subsidiaries are included in the consolidated financial statements from the date that control commenced until the date control ceases. Control exists when the Company has the power directly or indirectly, to govern the financial and operating policies of an entity so as to obtain benefits from its activities. The Company applies the acquisition method to account for business combinations in accordance with IFRS 3.

 

All inter–company balances, and transactions, have been eliminated upon consolidation.

 

3. Significant Accounting Policies

 

Cash and cash equivalents

 

Cash and cash equivalents include cash on hand, deposits held with banks and other short-term highly liquid investments with original maturities of three months or less. As at July 31, 2020 and 2019, the Company had no cash equivalents.

 

 F-7 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

3. Significant Accounting Policies (continued)

 

Translation of Foreign Currencies

 

These consolidated financial statements are presented in Canadian dollars. The functional currency of BriaCell is the Canadian dollar. The functional currency of BTC and Sapientia is the United States dollar.

 

Translation gains or losses resulting from the translation of the financial statements of BTC and Sapientia into Canadian dollars for presentation purposes are recorded in other comprehensive loss.

 

Within each entity, transactions in currencies other than the functional currency (“foreign currencies”) are translated to the functional currency at the rate of exchange prevailing at the date of the transaction. Monetary assets and liabilities denominated in foreign currencies are retranslated to the functional currency at the end of each reporting period at the period-end exchange rate. Exchange gains and losses on the settlement of transactions and the translation of monetary assets and liabilities to the functional currency are recorded in profit or loss.

 

Intangible assets

 

Separately acquired intangible assets are measured on initial recognition at cost including directly attributable costs. Intangible assets acquired in a business combination are measured at fair value at the acquisition date. Expenditures relating to internally generated intangible assets, excluding capitalized development costs, are recognized in profit or loss when incurred.

 

Intangible assets with finite useful lives are amortized over their useful lives and reviewed for impairment whenever there is an indication that the asset may be impaired. The amortization period and the amortization method for an intangible asset are reviewed at least at each year end.

 

Intangible assets with indefinite useful lives are not systematically amortized and are tested for impairment annually, or whenever there is an indication that the intangible asset may be impaired. The useful life of these assets is reviewed annually to determine whether their indefinite life assessment continues to be supportable. If the events and circumstances do not continue to support the assessment, the change in the useful life assessment from indefinite to finite life is accounted for prospectively as a change in accounting estimate and on that date the asset is tested for impairment. Commencing from that date, the asset is amortized systematically over its useful life.

 

The useful lives of intangible assets are as follows:

 

      Patents  
         
Useful life     20 years  
Amortization method     Straight-line  
In-house development or purchase     Purchase  

 

 F-8 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

3. Significant Accounting Policies (continued)

 

Impairment of non-financial assets

 

The Company evaluates the need to record an impairment of non-financial assets whenever events or changes in circumstances indicate that the carrying amount is not recoverable.

 

If the carrying amount of non-financial assets exceeds their recoverable amount, the assets are reduced to their recoverable amount. The recoverable amount is the higher of fair value less costs of sale and value in use. In measuring value in use, the expected future cash flows are discounted using a pre-tax discount rate that reflects the risks specific to the asset. The recoverable amount of an asset that does not generate independent cash flows is determined for the cash generating unit (“CGU”) to which the asset belongs. Impairment losses are recognized in profit or loss.

 

An impairment loss of an asset, other than goodwill, is reversed only if there have been changes in the estimates used to determine the asset’s recoverable amount since the last impairment loss was recognized. Reversal of an impairment loss, as above, shall not be increased above the lower of the carrying amount that would have been determined (net of depreciation or amortization) had no impairment loss been recognized for the asset in prior years and its recoverable amount. The reversal of impairment loss of an asset presented at cost is recognized in profit or loss.

 

Research and Development

 

The Company expenses amounts paid for intellectual property, development and production expenditures as they are incurred. However, such costs are deferred and recorded in intangible assets when they meet generally accepted criteria, to the extent that their recovery can reasonably be regarded as assured.

 

The costs must meet the following criteria to be deferred: the technical feasibility of completing the intangible asset so that it will be available for use or sale; the intention to complete the intangible asset and use or sell it; the ability to use or sell the intangible asset; the probability of future economic benefits; the availability of adequate technical, financial and other resources to complete the development and to use or sell the intangible asset; and the ability to reliably measure the expenditure attributable to the intangible asset during its development.

 

Once those criteria are met, the future costs, such as costs to obtain patent or trademark protection over the developed technologies, will be capitalized. These costs are then amortized over their expected useful lives. To date it has not been demonstrated that these expenditures will generate or be able to be used to generate probable future economic benefits.

 

 F-9 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

3. Significant Accounting Policies (continued)

 

Financial Instruments

 

In July 2014, the IASB published IFRS 9 which replaces IAS 39, “Financial Instruments: Recognition and Measurement”. IFRS 9 introduces improvements which include a logical model for classification and measurement of financial instruments, a single, forward-looking “expected credit loss” impairment model and a substantially reformed approach to hedge accounting. IFRS 9 was effective for annual reporting periods beginning on or after January 1, 2018.

 

The Company adopted IFRS 9 on August 1, 2018 and has elected not to restate the comparative information for prior periods with respect to classification and measurement (including impairment) requirements. Therefore, comparative periods have not been restated. There were no differences in the carrying amounts of financial assets and financial liabilities from adoption of IFRS 9. Accordingly, the information presented for July 31, 2018 does not generally reflect the requirements of IFRS 9 but rather those of IAS 39. The adoption of IFRS 9 resulted in changes in classification which are described below.

 

a) Classification

 

In implementing IFRS 9, the Company updated the financial instruments classification within its accounting policy. The following table shows the original classification under IAS 39 and the new classification under IFRS 9:

 

Financial asset/liability   Classification under   Classification under
    IAS 39   IFRS 9
Cash and cash equivalents   Loans and receivables   Amortized cost
Amounts receivable   Loans and receivables   Amortized cost
Accounts payable   Other financial liabilities   Amortized cost
Short term loans   Other financial liabilities   Amortized cost
Convertible debt   Other financial liabilities   FVTPL

 

The Company determines the classification of financial instruments at initial recognition. The classification of its instruments is driven by the Company’s business model for managing the financial assets and their contractual cash flow characteristics. Equity instruments that are held for trading (including all equity derivative instruments) are classified as fair value through profit and loss (“FVTPL”). For other equity instruments, on the day of acquisition, the Company can make an irrevocable election (on an instrument-by-instrument basis) to designate them at fair value through other comprehensive income (“FVTOCI”). Financial liabilities are measured at amortized cost, unless they are required to be measured at FVTPL (such as instruments held for trading or derivatives) or the Company has opted to measure them at FVTPL.

 

 F-10 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

3. Significant Accounting Policies (continued)

 

Financial Instruments (continued)

 

b) Measurement

 

Financial assets and liabilities:

 

Financial instruments carried at FVTPL are initially recorded at fair value and transaction costs are expensed in the consolidated statements of operations and comprehensive loss. Realized and unrealized gains and losses arising from changes in the fair value of the financial assets held at FVTPL are included in the statements of operations and comprehensive loss in the period in which they arise. Where the Company has opted to recognize a financial liability at FVTPL, any changes associated with the Company’s own credit risk will be recognized in other comprehensive income (loss).

 

Financial instruments carried at FVTOCI for other equity instruments, on the day of acquisition the Company can make an irrevocable election (on an instrument-by-instrument basis) to designate them at fair value through other comprehensive income.

 

After initial recognition, other financial liabilities are subsequently measured at amortized costs using the effective interest rate method (“EIR”). Gains and losses are recognized in the consolidated statements of operations and comprehensive loss when the liabilities are derecognized, as well as through the EIR amortization process.

 

Amortized cost is calculated by taking into account any discount or premium on acquisition and fees or costs that are an integral part of EIR. The EIR amortization is included as an interest expense in the consolidated statement of operations and comprehensive loss.

 

c) Impairment of financial assets at amortized cost

 

The Company recognizes a loss allowance for expected credit losses on financial assets that are measured at amortized cost. At each reporting date, the Company measures the loss allowance for the financial asset at an amount equal to the lifetime expected credit losses if the credit risk on the financial asset has increased significantly since initial recognition. If at the reporting date, the financial asset has not increased significantly since initial recognition, the Company measures the loss allowance for the financial asset at an amount equal to twelve month expected credit losses. The Company recognizes an impairment gain or loss, the amount of expected credit losses (or reversal) that is required to adjust the loss allowance at the reporting date to the amount that is required to be recognized.

 

 F-11 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

3. Significant Accounting Policies (continued)

 

Share-based Payments

 

Equity-settled share-based payments for directors, officers and employees are measured at fair value at the date of grant and recorded as compensation expense over the vesting period with a corresponding increase to share-based payment reserve in the consolidated financial statements.

 

The fair value determined at the grant date of equity-settled share-based payments is expensed using the graded vesting method over the vesting period based on the Company’s estimate of payments that will eventually vest. Upon exercise of the stock options, consideration paid by the option holder together with the amount previously recognized in share-based payment reserve is recorded as an increase to share capital. Upon expiry, the amounts recorded for share-based compensation are transferred to the deficit from the share-based payment reserve. Shares are issued from treasury upon the exercise of equity-settled share-based instruments.

 

Compensation expense on stock options granted to non-employees is measured at the earlier of the completion of performance and the date the options are vested using the fair value method and is recorded as an expense in the same period as if the Company had paid cash for the goods or services received.

 

When the value of goods or services received in exchange for the share-based payment cannot be reliably estimated, the fair value is measured by use of a Black-Scholes valuation model. The expected life used in the model is adjusted, based on management’s best estimate, for the effects of non-transferability, exercise restrictions, and behavioral considerations.

 

Share Capital

 

Common shares are classified as equity. Proceeds from unit placements are allocated between shares and warrants issued using the relative fair value method. Costs directly identifiable with share capital financing are charged against share capital. Share issuance costs incurred in advance of share subscriptions are recorded as prepaid assets. Share issuance costs related to uncompleted share subscriptions are charged to operations in the period they are incurred.

 

Warrant Reserve

 

The fair value of warrants is determined upon their issuance either as part of unit private placements or in settlement of share issuance costs and finders’ fees, using the Black-Scholes model. All such warrants are classified in a warrant reserve within equity. If the warrants are converted, the value attributable to the warrants is transferred to common share capital. Upon expiry, the amounts recorded for expired warrants is transferred to the deficit from the warrant reserve. Shares are issued from treasury upon the exercise of share purchase warrants.

 

 F-12 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

3. Significant Accounting Policies (continued)

 

Income Taxes

 

Income tax expense consists of current and deferred tax expense. Current and deferred taxes are recognized in profit or loss except to the extent they relate to items recognized directly in equity or other comprehensive income.

 

Current tax is recognized and measured at the amount expected to be recovered from or payable to the taxation authorities based on the income tax rates enacted or substantively enacted at the end of the reporting period and includes any adjustment to taxes payable in respect of previous years.

 

Deferred tax is recognized on any temporary differences between the carrying amounts of assets and liabilities in the consolidated financial statements and the corresponding tax bases used in the computation of taxable earnings. Deferred tax assets and liabilities are measured at the tax rates that are expected to apply in the period when the asset is realized and the liability is settled. The effect of a change in the enacted or substantively enacted tax rates is recognized in loss and comprehensive loss or equity depending on the item to which the adjustment relates.

 

Deferred tax assets are recognized to the extent future recovery is probable. At the end of each reporting period, deferred tax assets are reduced to the extent that it is no longer probable that sufficient taxable earnings will be available to allow all of part of the asset to be recovered.

 

Basic and Diluted Loss per Share

 

Basic loss per share is computed by dividing the loss for the year by the weighted average number of common shares outstanding during the year. Diluted earnings per share reflect the potential dilution that could occur if potentially dilutive securities were exercised or converted to common stock.

 

The dilutive effect of options and warrants and their equivalent is computed by application of the treasury stock method. Diluted amounts are not presented when the effect of the computations is anti-dilutive. Accordingly, at present, there is no difference in the amounts presented for basic and diluted loss per share.

 

Government Grants

 

Government grants are recognized when there is reasonable assurance that the grant will be received, and all conditions associated with the grant are met. Grants related to assets are recorded as a reduction to the asset’s carrying value and are depreciated over the useful like of the asset. Claim under the government grant related to income are recorded as other income in the period in which eligible expenses are incurred or when the services have been performed.

 

 F-13 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

3. Significant Accounting Policies (continued)

 

Accounting Standards Implemented as at August 1, 2019

 

IFRS 16 - Leases (“IFRS 16”)

 

IFRS 16 supersedes IAS 17 Leases, IFRIC 4 Determining whether an arrangement contains a lease, SIC-15 Operating Leases - Incentives and SIC-27 Evaluating the Substance of Transactions Involving the Legal Form of a Lease. It eliminates the distinction between operating and finance leases from the perspective of the lessee. All contracts that meet the definition of a lease will be recorded in the consolidated statements of financial position with a “right of use” asset and a corresponding liability. The asset is subsequently accounted for as property, plant and equipment or investment property and the liability is unwound using the interest rate inherent in the lease. The Company has adopted IFRS 16 as of August 1, 2019, and has assessed no changes to the opening consolidated statements of financial position as a result of the adoption of this new standard.

 

On transition to IFRS 16, the Company has elected to apply the practical expedient to grandfather the assessment of which transactions are leases and apply IFRS 16 only to contracts that were previously identified as leases. Contracts that were not identified as leases under IAS 17 Leases have not been reassessed for whether a lease exists. The Company has elected to not recognize right-of-use assets and lease liabilities for leases that have a lease term of 12 months or less and for leases of low-value assets.

 

IFRIC 23 - Uncertainty over Income Tax Treatments (“IFRIC 23”)

 

The Company adopted IFRIC 23 on July 1, 2019 on a modified retrospective basis without restatement of comparative information. The interpretation requires an entity to assess whether it is probable that a tax authority will accept an uncertain tax treatment used, or proposed to be used, by an entity in its income tax filings and to exercise judgment in determining whether each tax treatment should be considered independently or whether some tax treatments should be considered together. The decision should be based on which approach provides better predictions of the resolution of the uncertainty. An entity also has to consider whether it is probable that the relevant authority will accept each tax treatment, or group of tax treatments, assuming that the taxation authority with the right to examine any amounts reported to it will examine those amounts and will have full knowledge of all relevant information when doing so. The adoption of the new standard had no impact on the consolidated financial statements as at July 31, 2020.

 

 F-14 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

3. Significant Accounting Policies (continued)

 

Accounting Standards Implemented as at August 1, 2019 (continued)

 

IFRS 3 - Business Combinations (“IFRS 3”)

 

In October 2018, the IASB issued an amendment to IFRS 3, effective for annual periods beginning on or after January 1, 2020 with early adoption permitted. The amendment clarifies that a business must include, at minimum, an input and a substantive process that together contribute to the ability to create outputs, and assists companies in determining whether an acquisition is a business combination or an acquisition of a group of assets by providing supplemental guidance for assessing whether an acquired process is substantive. The Company has decided to early adopt the amendments to IFRS 3 effective August 1, 2019 and shall apply the amended standard in assessing business combinations on a prospective basis. For acquisitions that are determined to be acquisitions of assets as opposed to business combinations, the Company allocates the transaction price to the individual identifiable assets acquired and liabilities assumed on the basis of their relative fair values, and no goodwill is recognized. Acquisitions that continue to meet the definition of a business combination are accounted for under the acquisition method, without any changes to the Company’s accounting policy. There was no impact on the Company’s consolidated financial statements as at July 31, 2020.

 

Significant Accounting Judgments and Estimates

 

The preparation of these consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and reported amounts of expenses during the reporting period. Actual outcomes could differ from these estimates. The consolidated financial statements include estimates which, by their nature, are uncertain. The impacts of such estimates are pervasive throughout the consolidated financial statements, and may require accounting adjustments based on future occurrences. Revisions to accounting estimates are recognized in the period in which the estimate is revised and also in future periods when the revision affects both current and future periods.

 

 F-15 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

3. Significant Accounting Policies (continued)

 

Significant Accounting Judgments and Estimates (continued)

 

The critical judgments and significant estimates in applying accounting policies that have the most significant effect on the amounts recognized in the consolidated financial statements are:

 

The series of loans made to the subsidiary company are considered part of the parent company’s net investment in a foreign operation as the Company does not plan to settle these balances in the foreseeable future. As a result of this assessment, the unrealized foreign exchange gains and losses on the intercompany loans are recorded through compressive loss. If the Company determined that settlement of these amounts was planned or likely in the foreseeable future, the resultant foreign exchange gains and losses would be recorded through profit or loss.
   
The change in the fair value of the unsecured convertible loan is based on an estimate determined by the Black-Scholes Model.
   
Preparation of the consolidated financial statement on a going concern basis, which contemplates the realization of assets and payments of liabilities in the ordinary course of business. Should the Company be unable to continue as a going concern, it may be unable to realize the carrying value of its assets, including its intangible assets and to meet its liabilities as they become due.
   
Intangible assets are tested for impairment annually or more frequently if three is an indication of impairment. The carrying value of intangibles with definite lives is reviewed each reporting period to determine whether there is any indication of impairment. If there are indications of impairment the impairment analysis is completed and if the carrying amount of an asset exceeds its recoverable amount, the asset is impaired and impairment loss is recognized.

 

 

4. Intellectual Property

 

The attributable intellectual property relates to Sapientia’s various patents, which the Company is amortizing over 20 years, consistent with its accounting policy. During the year ended July 31, 2020, the Company recorded $18,741 in amortization on intellectual property (2019 - $18,743).

 

Costs     Accumulated Amortization     Net Book Value  
July 31, 2019:                                      
July 31, 2018     Additions     July 31, 2019     July 31, 2018     Amortization during the year     July 31, 2019     July 31, 2019  
$ 374,852     $ -     $ 374,852     $ 16,894     $ 18,743     $ 35,637     $ 339,215  
                                                     
July 31, 2020:                                                  
  July 31, 2019       Additions       July 31, 2020       July 31, 2019       Amortization during the year       July 31, 2020       July 31, 2020  
$ 374,852     $ -     $ 374,852     $ 35,637     $ 18,741     $ 54,378     $ 320,474  

 

 F-16 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

5. Loans

 

(a) Short-terms loans

 

On December 3, 2019, January 27, 2020 and February 20, 2020 and the Company received three unsecured loan from a third party in the amounts of US$100,000, US$50,000 and US$50,000, respectively “Short Term Loans”). The Short Term Loans all bear interest at 2.5% annually and were all repayable on or before March 26, 2020, after which the interest rate increased to 15% annually, however, the loan holder has deferred the increased interest to November 20, 2020. The Short Term Loans remain outstanding as of the date of this report.

 

On April 30, 2020 and May 20, 2020, the Company received two loans from other third parties in the total amount of US$20,000. These loans all bear interest at 10% annually are repayable on or before December 31, 2020.

 

Total interest expense in respect to the short-term loans was $33,939 for the year ended July 31, 2020 ($nil for the year ended July 31, 2019).

 

(b) Government grants

 

On April 24, 2020, the Company received a $40,000 loan from the Canada Emergency Business Account (“CEBA Loan”). The CEBA Loan bears 0% interest until December 31, 2022. If the balance is not paid by December 31, 2022, the remaining balance will be converted to a 3-year term loan at 5% annual interest, paid monthly, effective January 1, 2023. The full balance must be repaid by no later than December 31, 2025. No principal payments required until December 31, 2022. Principal repayments can be voluntarily made at any time without fees or penalties. $10,000 loan forgiveness is available, provided the outstanding balance is $40,000 at December 31, 2020, and $30,000 is paid back between January 1, 2021 and December 31, 2022. The loan was recognized at the fair value based on an estimated market interest rate of 15%. The Company made no interest payments during the year ended July 31, 2020 and recorded a gain from the government grant in the amounts of $13,121 (2019 – nil, 2018 – nil) which represents the benefit of receiving an interest free grant.

 

On May 1, 2020 the Company received US$127,030 as a loan from the Paycheck Protection Program in the United States (the “Program”) The terms of the Program provide that a portion of the loan may be forgiven, to the extent that the amounts spent during the eight week period following the first disbursement of the loan are incurred as follows: (i) payroll costs, (ii) interest payments on mortgages incurred before February 15, 2020, (iii) rent payments on leases in effect before February 15, 2020, and (iv) utility payments for which service began before February 15, 2020 (“Program Expenses”). The unforgiven part of the loan must be repaid within two years and bears interest at 1% per annum. The Company used the entire proceeds to pay Program expenses and is currently in the process of applying to have this loan forgiven. The loan was recognized at the fair value based on an estimated market interest rate of 15%. The Company made no interest payments during the year ended July 31, 2020 and recorded a gain from the government grant in the amount of $15,483 (2019 – nil, 2018 – nil) which represents the benefit of receiving a loan with 1% interest.

 

 F-17 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

6. Unsecured convertible loan

 

On March 16, 2018, concurrent with the non-brokered unit offering (Note 7(b)(iv)), the Company completed a non-brokered private placement for the purchase of 5.0% unsecured convertible notes (each, a “Convertible Note”) in the principal amount of US$885,000. Under the terms of securities purchase agreements between the Company and the purchasers of Convertible Notes (the “Noteholders”), each Convertible Note is convertible, at the option of the holder, into (i) common shares of BriaCell for so long as the Convertible Note is outstanding, at a fixed conversion price of $30.00 per common share, for a period of nine months from the date of issuance, which may be extended by the applicable holder and (ii) for each common share issued as a result of conversion, one warrant. The warrants are valid for 36 months from their issuance date and each warrant is exercisable for one common share at an exercise price of $42.00. On April 23, 2019, the Company revised the exercise price of these warrants from $42.00 to $36.00.

 

The original repayment date of the Convertible Notes was September 16, 2018. On September 17, 2018, the Company and the Noteholders agreed to extend the repayment date of the Convertible Notes to March 20, 2019 and on March 8, 2019, the Company and the Noteholders agreed to extend the repayment date of the Convertible Notes, to September 7, 2019.

 

During the year ended July 31, 2018, the Noteholders converted $106,843 of Convertible Notes into 3,561 shares and 3,561 warrants.

 

During the year ended July 31, 2019, $674,645 of Convertible Notes were converted and as such, the Company issued 22,488 shares and 22,488 warrants on conversion.

 

On September 10, 2019, the Company repaid the balance of the Convertible Notes in the total amount of $477,599 (US$ 362,819).

 

The Convertible Notes are denominated in US dollars and convertible into common shares and warrants based on the principal and interest balance translated to Canadian dollars. Management determined that the Convertible Notes represent a combined instrument that contains an embedded derivative, being the conversion option. As a result of the foreign exchange impact on the conversion factor, the conversion option does not meet the fixed for fixed criteria and therefore represents a derivative liability. In accordance with IFRS 9, the Company has designated the entire Unsecured Convertible Loan at fair value through profit or loss. The Unsecured Convertible Loan was initially recorded at fair value and re-valued at each reporting date with changes in fair value being charged to interest expenses in the consolidated statements of operations and comprehensive loss.

 

Fair value determination

 

The fair value of the Convertible Notes, including any adjustments thereto, has been determined using a combination of the Black-Scholes option pricing model for the equity conversion portion and the discounted cash flow method for the loan portion.

 

 F-18 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

6. Unsecured convertible loan (continued)

 

The following assumptions were used to determine the fair value of the Convertible Notes:

 

   

September 10, 2019

(at the repayment date)

   

July 31, 2019

(at year end)

 
Risk-free interest rate     1.6 %     2.03 %
Expected volatility     57 %     76 %
Share price   $ 19.50     $ 19.50  
Expected dividend yield     0 %     0 %
Annual loan interest rate     5 %     5 %
CAD/USD exchange rate     1.3153       1.3148  

 

Total interest expense and loss due to the change in fair value, charged to the consolidated statements of operations and comprehensive loss for the years ended July 31, 2020, 2019 and 2018 are as follows:

 

    Year ended  
    July 31,  
    2020     2019     2018  
                   
Interest expense   $ 2,256     $ 31,317     $ 20,364  
Change in fair value   $ (79,119 )   $ 420,585     $ (407,709 )

 

 

7. Share Capital and Warrant Reserve

 

  a) Authorized share capital

 

The authorized share capital consists of an unlimited number of common shares with no par value.

 

Retroactive Adjustment for Reverse Stock Split

 

In December 2019, the Board and TSX-V approved a 1-for-300 reverse stock split, or the Reverse Split, which was implemented effective January 2, 2020. Consequently, all share numbers, share prices, and exercise prices have been retroactively adjusted in these condensed interim consolidated financial statements for all periods presented.

 

 F-19 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

7. Share Capital and Warrant Reserve (continued)

 

  b) Issued share capital

 

During the years ended July 31, 2018, 2019 and 2020, the Company issued shares as follows:

 

  i) On August 2, 2017, the Company and the Company’s President and CEO completed a non-brokered private placement resulting in gross proceeds of $631,785. The non-brokered private placement involved the sale of 13,528 shares at a price of $48.00 per unit.
     
  ii) On September 5, 2017, the Company issued 8,333 common shares to the Sapientia shareholders as consideration for the acquisition of all outstanding shares in the capital of Sapientia.
     
  iii) On October 13, 2017, the Company introduced a warrant exercise incentive program (the “Warrant Incentive Program”) designed to encourage the early exercise of up to approximately 26 million outstanding common share purchase warrants (the “Warrants”).Under the terms of the Warrant Incentive Program, the Company offered the following inducements: (i) a temporary reduction in the respective exercise prices of the Warrants to $42.00, consistent with the current trading value of BriaCell’s shares, for each Warrant that is exercised on or before November 30, 2017 (the “Early Exercise Period”); and (ii) for each Warrant exercised during the Early Exercise Period, the holder will receive, at no additional cost, one-half of one newly issued common share purchase warrant (each an “Incentive Warrant”), with each whole Incentive Warrant exercisable into one common share for a period of 24 months from the issue date at an exercise price of $60.00. Any Warrants that are not exercised prior to the expiry of the Early Exercise Period will remain outstanding in accordance with their original terms, and in particular, will no longer be eligible for the reduced exercise price or issuance of Incentive Warrants. In total, 6,810 warrants were exercised in connection with the Warrant Incentive Program at an exercise price of $42.00 for aggregate gross proceeds of $286,020. In addition, a total of 3,405 Incentive Warrants were granted in connection with the Warrant Incentive Program, with each Incentive Warrant entitling the holder to purchase one additional common share of the Company at an exercise price of $60.00, expiring December 21, 2019. The fair value of the warrants was $65,537. The fair value was estimated using the Black-Scholes option pricing model and the following weighted average assumptions: share price - $48.00; exercise price - $60.00; expected life - 24 months; annualized volatility - 114.68%; dividend yield - 0%; risk free rate - 1.66%.

 

 F-20 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

7. Share Capital and Warrant Reserve (continued)

 

  b) Issued share capital (continued)

 

  iv) On March 27, 2018, the Company completed a brokered private placement (the “March 2018 Brokered Unit Offering”) of 144,408 units of the Company (the “March 2018 Units”) at a price of $30.00 per March 2018 Unit for aggregate gross proceeds of $4,332,232. Under the Brokered Unit Offering, each March 2018 Unit consists of one common share and one common share purchase warrant (each, a “March 2018 Warrant”). The March 2018 Warrants are valid for 36 months following the closing of the Brokered Unit Offering and each March 2018 Warrant is exercisable for one Common Share at an exercise price of $42.00. In connection with the March 2018 Brokered Unit Offering and the Note Offering (together, the “Offerings”), the Company paid commissions to certain participating dealers on a portion of funds raised. In respect of the March 2018 Brokered Unit Offering, aggregate cash commissions of $235,215 and an aggregate 8,711 broker warrants (the “March 2018 Broker Warrants”) were paid. The March 2018 Broker Warrants issued in connection with the Offerings are exercisable into one Common Share at an exercise price of $42.00 for a period of 36 months from the issue date. The fair value of March 2018 Warrants and March 2018 Broker Warrants was $1,479,028 and $208,545, respectively, and was determined using the Black-Scholes option pricing model and the following assumptions: share price - $39.00; exercise price - $42.00; expected life - 36 months; annualized volatility - 100.61%; dividend yield - 0%; risk free rate - 1.99%. Officers and members of the Company’s Board of Directors, including BriaCell’s Chief Executive Officer, Chief Financial Officer and the Board’s Chairman (the “Related Parties”), participated in the Brokered Unit Offering, which participation constitutes a “related party transaction” as defined under Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions (“MI 61-101”) and TSX Venture Exchange policy 5.9. Such related party transaction is exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 as neither the fair market value of securities being issued to the related parties nor the consideration being paid by the related parties exceeded 25% of the Company’s market capitalization.
     
  v) During July 2018, the Company issued 3,561 shares at $30.00 per share in respect of the partial conversion of certain Convertible Notes (Note 6). Upon exercise of these Convertible Notes, the Noteholders received 3,561 warrants with an exercise price of $42.00, expiring in July 31, 2021. The fair value of the warrants was $40,435. The fair value was estimated using the Black-Scholes option pricing model and the following weighted average assumptions: share price - $42.00; exercise price - $42.00; expected life - 36 months; annualized volatility - 100.41%; dividend yield - 0%; risk free rate - 2.12%.

 

 F-21 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

7. Share Capital and Warrant Reserve (continued)

 

  b) Issued share capital (continued)

 

  vi) During the year ended July 31, 2019, 22,488 shares were issued at $30.00 per share in respect of the partial conversion of certain Convertible Notes (Note 6). Upon exercise of these Convertible Notes, the Noteholders received 22,488 warrants with an exercise price of $42.00, expiring within three years. The fair value of the warrants was $266,526. The fair value was estimated using the Black-Scholes option pricing model and the following weighted average assumptions: share price - $31.50-$40.50; exercise price - 42.00; expected life - 36 months; annualized volatility - 100.7%-70.6%; dividend yield - 0%; risk free rate - 1.6%-2.3%.
     
  vii) On September 28, 2018, 3,333 shares were issued in respect of 3,333 warrants that were exercised at an exercise price of $42.00 for gross proceeds of $140,000. The fair value of the warrants in the amount of $34,140 were released from the Warrant reserve to Share Capital.
     
  viii) On March 25, 2019 and April 1, 2019, the Company completed a non brokered private placement (the “April 2019 Private Placement”) of 99,117 shares of the Company at a price of $30.00 per share for aggregate gross proceeds of $2,973,524 (net proceeds: $2,855,784). Included in the April 2019 Private Placement were $500,000 from Mr. Jamieson Bondarenko, an insider of the Company, and his participation in the April 2019 Private Placement is considered a “related party transaction” pursuant to Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”). The Company is exempt from the requirements to obtain a formal valuation or minority shareholder approval in connection with the insiders’ participation in the Private Placement in reliance of sections 5.5(a) and 5.7(1)(a) of MI 61-101.
     
  ix) On September 9, 2019, the Company completed a non brokered private placement of 40,300 common shares at a price of $21.00 per common share for gross proceeds of $846,300.
     
  x) On October 15, 2019, the Company completed non brokered private placement of 27,069 common shares at a price of $21.00 per common share for gross proceeds of $568,444.

 

 F-22 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

7. Share Capital and Warrant Reserve (continued)

 

  c) Share Purchase Warrants

 

A summary of changes in share purchase warrants for the years ending July 31, 2020, 2019 and 2018 is presented below:

 

    Number Of Warrants     Weighted Average Exercise Price  
Balance, July 31, 2017     100,581     $ 90  
                 
Exercised on Warrant Incentive Program (Note 7(b)(iii))     (6,810 )     42  
Granted on Warrant Incentive Program (Note 7(b)(iii))     3,405       60  
Granted on Brokered Unit Offering (Note 7(b)(iv))     144,408       42  
Granted from conversion of Notes (Note 7(b)(v))     3,561       42  
Expired during the year (i)     (43,650 )     (78 )
Balance, July 31, 2018     201,495       57  
Granted from conversion of Convertible Notes (Note 7(b)(xii))     22,488       42  
Exercised Brokered Unit Offering (Note 7(b)(xii))     (3,333 )     42  
Expired during the year (ii)     (10,384 )     105  
Balance, July 31, 2019     210,266       54  
Expired during the year (iii)     (31,738 )     105  
Balance, July 31, 2020     178,528       44  

 

  i. During the year ended July 31, 2018, 43,650 warrants with a fair value of $679,039 expired and the Company recorded a charge to the warrant reserve with a corresponding credit to accumulated deficit.
  ii. During the year ended July 31, 2019, 10,384 warrants with a fair value of $269,282 expired and the Company recorded a charge to the warrant reserve with a corresponding credit to accumulated deficit.
  iii. During the year ended July 31, 2020, 31,738 warrants with a fair value of $533,334 expired and the Company recorded a charge to the warrant reserve with a corresponding credit to accumulated deficit.

 

 F-23 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

7. Share Capital and Warrant Reserve (continued)

 

  c) Share Purchase Warrants (continued)

 

As at July 31, 2020, warrants outstanding were as follows:

 

Number of     Exercise     Exercisable At     Expiry  
Warrants     Price     July 31, 2020     Date  
                     
  11,404     $       90       11,404       April 26, 2021  
  141,074     $ 42       141,074       March 27, 2021  
  26,050     $ 36       26,050       October 2021-July 2022  
  178,528               178,528          

 

  d) Compensation Warrants

 

A summary of changes in compensation warrants for the years ended July 31, 2020, 2019 and 2018 is presented below:

 

    Number Of Warrants     Weighted Average Exercise Price  
              -  
Balance, July 31, 2017     3,358     $ 60  
              -  
Grant on brokered private placement (Note 7(b)(iv))     8,711       42  
Grant from placement of Convertible Notes (Note 6)     4,167       42  
Expired during 2018 (i)     (463 )     (60 )
Balance, July 31, 2018 and 2019     15,773     $ 45  
Expired during the year (ii)     (1,983 )     60  
Balance, July 31, 2020     13,790     $ 45  

 

  (i) During the year ended July 31, 2018, 463 compensation warrants with a fair value of $15,418 expired and the Company recorded a charge to the warrant reserve with a corresponding credit to accumulated deficit
  (ii) During the year ended July 31, 2019, 1,983 compensation warrants with a fair value of $65,198 expired and the Company recorded a charge to the warrant reserve with a corresponding credit to accumulated deficit.

 

 F-24 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

7. Share Capital and Warrant Reserve (continued)

 

  d) Compensation Warrants (continued)

 

As at July 31, 2020, compensation warrants outstanding were as follows:

 

Number Of                    
Compensation     Exercise     Exercisable at        
Warrants     Price     Jul 31, 2020     Expiry Date  
                     
  912     $ 90       912       April 26, 2021 (i)  
  4,167     $ 42       4,167       March 27, 2021 (ii)  
  8,711     $ 42       8,711       March 27, 2021 (ii)  
  13,790               13,790          

 

  i. Each compensation warrant can be exercised at $90.00 into one unit of BriaCell comprising one common share and one share purchase warrant. Each resultant share purchase warrant acquired can be exercised into an additional common share of BriaCell at $105.00 if exercised by April 26, 2021.
  ii. Each compensation warrant can be exercised at $42.00 into one common share of BriaCell for a period of 36 months.

 

 

8. Share-Based Compensation and Share-Based Payment Reserve

 

The Company has adopted a stock option plan (the “Plan”) under which it is authorized to grant options to officers, directors, employees and consultants enabling them to acquire up to 10% of the issued and outstanding common stock of the Company. The options can be granted for a maximum of 5 years and vest as determined by the Board of Directors. The exercise price of each option granted may not be less than the fair market value of the common shares at the time of grant.

 

A summary of changes in stock options for the years ended July 31, 2020, 2019 and 2018 is presented below:

 

   

Number of options

outstanding

   

Weighted average
exercise price

 
Balance, July 31, 2017     20,274     $ 72  
Granted (i)     20,552       45  
Cancelled     (583 )     (90 )
Expired (ii)     (8,833 )     (69 )
Balance, July 31, 2018     31,410     $ (246 )
Expired (iii)     (2,167 )     (111 )
Cancelled     (6,000 )     (54 )
Balance, July 31, 2019     23,243     $ (249 )
Granted (iv)     166       62  
Expired     (3,440 )     (48 )
Balance, July 31, 2020     19,969       49  

 

 F-25 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

8. Share-Based Compensation and Share-Based Payment Reserve (continued)

 

i. During the year ended July 31, 2018, the Company issued a total of 20,552 options, as follows:
   
a. On May 1, 2018, the Company issued 8,385 stock options to two consultants of which 25% vested immediately, and 25% vest every 90 days thereafter.
   
    The fair value of the 6,667 stock options was $126,579. The fair value was estimated using the Black-Scholes option pricing model with the following weighted average assumptions: share price - $30.00; exercise price - $42.00; expected life - 36 months; annualized volatility - 99.64%; dividend yield - 0%; risk free rate - 1.88%.
   
    The fair value of the 1,667 stock options was $30,165. The fair value was estimated using the Black-Scholes option pricing model with the following weighted average assumptions: share price - $30.00; exercise price - $60.00; expected life - 45 months; annualized volatility - 99.22%; dividend yield - 0%; risk free rate - 1.88%.
     
    The fair value of the 52 stock options was $988. The fair value was estimated using the Black-Scholes option pricing model with the following weighted average assumptions: share price - $30.00; exercise price - $42.00; expected life - 36 months; annualized volatility - 99.64%; dividend yield - 0%; risk free rate - 1.88%.
     
  b. On March 1, 2018, the Company issued 11,333 stock options to directors, officers, employees and consultants of the Company, which vested immediately. The fair value of the stock options was $239,119. The fair value was estimated using the Black-Scholes option pricing model with the following weighted average assumptions: share price - $30.00; exercise price - $45.00; expected life - 36 months; annualized volatility - 101.08%; dividend yield - 0%; risk free rate - 1.99%.
     
  c. On July 1, 2018, the Company issued 833 stock options to a consultant of the Company, which vest in in four grants of 208 options each three months. The fair value of the stock options was $18,916. The fair value was estimated using the Black-Scholes option pricing model with the following weighted average assumptions: share price - $45.00; exercise price - $51.00; expected life - 5 years; annualized volatility - 99.74%; dividend yield - 0%; risk free rate - 2.04%.
     
ii. During the year ended July 31, 2018, 8,333 options with a fair value of $357,842 expired and the Company recorded a charge to the share-based payment reserve with a corresponding credit to accumulated deficit.
   
iii.

During the year ended July 31, 2019, 6,000 options were cancelled and 2,167 options expired, with a total fair value of $88,754 and the Company recorded a charge to the share-based payment reserve with a corresponding credit to accumulated deficit.

 

 F-26 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

8. Share-Based Compensation and Share-Based Payment Reserve (continued)

 

iv. On September 9, 2019, the Company issued a total of 166 stock options to a consultant, which vested immediately and expire on September 9, 2024. The fair value of the stock options was $17,794. The fair value was estimated using the Black-Scholes option pricing model and the following weighted average assumptions: share price - $16.50; exercise price - $21; expected life - 5 years; annualized volatility - 88%; dividend yield - 0%; risk free rate – 1.4%

 

v. During the year ended July 31, 2020, 3,440 options expired, as follows:

 

  a. On November 1, 2019, 2,107 stock options with a fair value of $84,981 expired and the Company recorded a charge to the share-based payment reserve with a corresponding credit to accumulated deficit.
     
  b. On February 14, 2020, 833 stock options with a fair value of $34,290 expired and the Company recorded a charge to the share-based payment reserve with a corresponding credit to accumulated deficit.
     
  c. On March 22, 2020, 500 stock options with a fair value of $20,696 expired and the Company recorded a charge to the share-based payment reserve with a corresponding credit to accumulated deficit.

 

vi. The Company recognized stock based compensation expense of $2,071 for the year ended July 31, 2020, (year ended July 31, 2018 - $60,586, year ended July 31, 2018 - $476,211) in relation to the vesting of options issued in previous years.

 

vii. As at July 31, 2020, stock options were outstanding for the purchase of common shares as follows:

 

Number of Options     Exercise Price     Exercisable At July 31,2020     Expiry Date
  667     $      77       667     November 4, 2025
  1,917     $ 77       1,917     November 4, 2020
  8,000     $ 45       8,000     Mar 1, 2021
  1,667     $ 60       1,667     March 10, 2022
  6,719     $ 42       6,719     May 1, 2021
  833     $ 42       833     July 1, 2023
  166     $ 21       166     September 9, 2024
  19,969               19,969      

 

As at July 31, 2020, stock options outstanding have a weighted average remaining contractual life of 0.98 years (July 31, 2018 – 1.74 years).

 

 F-27 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

9. Income Taxes

 

The provision for taxes differs from the amount obtained by applying the combined Canadian Federal and Provincial statutory income tax rate of 27% (2019 - 27%) to the effective tax rate is as follows:

 

   

Year Ended

   

Year Ended

 
    July 31, 2020     July 31, 2019  
             
Net loss before recovery of income taxes   $ (4,944,221 )   $ (5,789,662 )

Expected income tax (recovery) expense

  $ (1,334,940 )   $ (1,563,209 )
Differences in foreign tax rates     (38,360 )     (52,740 )
Tax rate changes and other adjustments     -       7,240  
Share-based compensation and non-deductible expenses     1,300       16,982  
Share issuance cost booked directly to equity     -       (31,736 )
Change in deferred tax assets not recognized     1,372,000       1,623,463  
                 
Income tax (recovery) expense   $ -     $ -  

 

Deferred Tax

 

The following table summarizes the components of deferred tax:

 

    July 31, 2020     July 31, 2019  
             
Deferred Tax Assets                
Operating tax losses carried forward- USA     92,620       101,510  
                 
Deferred tax liabilities                
Intellectual property     (92,620 )     (98,033 )
Convertible debentures     -       (3,477 )
                 
    $ -     $ -  

 

Unrecognized Deferred Tax Assets

 

Deferred taxes are provided as a result of temporary differences that arise due to the differences between the income tax values and the carrying amount of assets and liabilities. Deferred tax assets have not been recognized in respect of the following deductible temporary differences because it is not probable that the future taxable profit will be available against which the Company can utilize the benefits:

 

 F-28 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

9. Income Taxes (continued)

 

The following table summarizes the components of the unrecognized deductible temporary differences:

 

    July 31, 2020     July 31, 2019  
             
Deferred Tax Assets                
Non-capital losses carried forward - USA   $ 14,951,440     $ 11,148,719  
Non-capital losses carried forward - Canada     5,349,060       4,219,013  
Short term loans     10,000       -  
Share issuance costs     370,460       570,483  
Marketable securities     107,000       106,998  
Property, plant and equipment - Canada     3,330       3,327  
Property, plant and equipment - USA             -  
                 
    $ 20,791,290     $ 16,048,540  

 

The Canadian and U.S. Losses expire as noted in the table below. Share issuance and financing costs will be fully amortized in 2024. The remaining deductible temporary differences may be carried forward indefinitely. Deferred tax assets have not been recognized in respect of these items because it is not probable that future taxable profit will be available against which the group can utilize the benefits therefrom.

 

 F-29 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

9. Income Taxes (continued)

 

The Company has Canadian non-capital income tax losses which expire as noted in the below table.

 

2035       767,440  
2036       467,980  
2037       573,270  
2038       1,250,140  
2039       1,056,060  
2040       1,234,170  
      $ 5,349,060  

 

The Company has U.S. tax loss carry forwards which expire as noted in the below table.

 

2033     $ 1,240  
2034       631,660  
2035       1,134,120  
2036       2,546,090  
Indefinite       10,638,330  
      $ 14,951,440  

 

 

10. Related Party Transactions and Balances

 

Parties are considered to be related if one party has the ability, directly or indirectly, to control the other party or exercise significant influence over the other party in making operating and financial decisions. This would include the Company’s senior management, who are considered to be key management personnel by the Company. Parties are also related if they are subject to common control or significant influence. Related parties may be individuals or corporate entities. A transaction is considered to be a related party transaction when there is a transfer of resources or obligations between related parties.

 

As at July 31, 2020, included in accounts payable and accrued liabilities are amounts owing to a company controlled by an officer in the amount of $52,500 (July 31, 2019 – $7,000) for consulting fees and amounts owing to directors of $602,287 (July 31, 2019– $26,200) for director’s fees.

 

During the years ended July 31, 2020, 2019 and 2018, the Company incurred the following expenses charged by directors and key management personnel or companies controlled by these individuals:

 

    Year ended  
    July 31,  
    2020     2019     2018  
                   
a) Paid or accrued professional fees to a company controlled by an officer of the Company   $ 42,000     $ 42,000     $ 42,000  
b) Paid or accrued consulting fees to companies controlled by individual directors.   $ 56,804     $ 121,112     $ 126,000  
c) Paid or accrued wages and consulting fees to directors   $ 541,310     $ 280,938     $ 263,365  
d) Share based compensation to directors and officers   $ -     $ -     $ 207,471  

 

 F-30 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

11. Capital Management

 

The Company’s capital comprises share capital, share-based payment reserve, warrant reserve, and accumulated other comprehensive loss. The Company manages its capital structure, and makes adjustments to it, based on the funds available to the Company in order to support the Company’s business activities. The Board of Directors does not establish quantitative return on capital criteria for management; it relies on the expertise of the Company’s management to sustain future development of the business.

 

The intellectual property in which the Company currently has an interest is in the development stage; as such, the Company is dependent on external financing to fund its activities. In order to carry out the planned research and development and pay for administrative costs, the Company intends to raise additional amounts as needed.

 

 

12. Financial Risk Factors

 

The Company’s risk exposures and the impact on the Company’s financial instruments are summarized below:

 

  a) Credit risk
     
    The Company has no significant concentration of credit risk arising from operations. Management believes that the credit risk concentration with respect to financial instruments is remote.
     
  b) Liquidity risk
     
    The Company’s approach to managing liquidity risk is to ensure that it will have sufficient liquidity to meet liabilities as they come due. As at July 31, 2020, the Company has a negative working capital balance of $4,548,526 (July 31, 2019 – negative working capital balance of $1,185,354) and long term loans of $306,878 (July 31, 2019 – nil). the Company has not yet achieved profitable operations and expects to incur further losses in the development of its products; these factors cast significant doubt about the Company’s ability to continue as a going concern.

 

 F-31 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

12. Financial Risk Factors (continued)

 

    Carrying amount     Contractual cash flows     Within 1 year     1-2 years     2-5 years     5+ years  
Accounts payable and accrued liabilities   $ 4,562,856     $ 4,562,856     $ 4,562,856     $ -     $ -     $ -  
Short-Term Loan     306,878       306,878       -       306,878       -       -  
Government grant     191,572       210,271       -       210,271       -       -  
    $ 5,061,306     $ 5,080,005     $ 4,562,856     $ 517,149     $ -     $ -  

 

Market Risk

 

  i. Interest rate risk
     
    Interest Rate risk is the risk that the fair value of a financial instrument will fluctuate because of changes in market interest rates. Loans payable include fixed interest rates; however, the Company does not believe it is exposed to material interest rate risk.
     
  ii. Price risk
     
    As the Company has no revenues, price risk is remote.
     
  iii. Exchange risk
     
    The Company is exposed to foreign exchange risk as a portion of the Company’s transactions occur in a foreign currency (mainly its research operations which are conducted primarily in the United States of America in US dollars) and, therefore, the Company is exposed to foreign currency risk at the end of the reporting period through its U.S. denominated accounts payable and cash. As at July 2020, a 5% depreciation or appreciation of the U.S. dollar against the Canadian dollar would have resulted in an approximate $175,000 (2019 - $45,000, 2018 - $55,000) decrease or increase, respectively, in total loss and comprehensive loss.

 

 F-32 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

12. Financial Risk Factors (continued)

 

  c) COVID-19

 

Since January 2020, the Coronavirus outbreak has dramatically expanded into a worldwide pandemic creating macro-economic uncertainty and disruption in the business and financial markets. Many countries around the world, including Canada and the United States have been taking measures designated to limit the continued spread of the Coronavirus, including the closure of workplaces, restricting travel, prohibiting assembling, closing international borders and quarantining populated areas. Such measures present concerns that may dramatically affect the Company’s ability to conduct its business effectively, including, but not limited to, adverse effect relating to employees’ welfare, slowdown and stoppage of manufacturing, commerce, shipping, delivery, work, travel and other activities which are essential and critical for maintaining on-going business activities. Given the uncertainty around the extent and timing of the future spread or mitigation of COVID-19 and around the imposition or relaxation of protective measures, the Company cannot reasonably estimate the impact to its future results of operations, cash flows or financial condition; infections may become more widespread and the limitation on the ability to work, travel and timely sell and distribute products, as well as any closures or supply disruptions, may be extended for longer periods of time and to other locations, all of which would have a negative impact on the Company’s business, financial condition and operating results. In addition, the unknown scale and duration of these developments have macro and micro negative effects on the financial markets and global economy which could result in an economic downturn that could affect demand for the Company’s products and have a material adverse effect on its operations and financial results, earnings, cash flow and financial condition.

 

 

13. Research and Development Costs

 

    Year ended  
    July 31,  
    2020     2019     2018  
                   
Wages and Salaries   $ 728,823     $ 855,864     $ 558,114  
Clinical Trials and Investigational drug costs     2,104,366       3,605,738       2,194,327  
Office Rent     33,707       51,316       69,871  
Licensing     2,110       241,990       34,967  
Supplies     -       25,715       81,915  
Insurance product     49,184       5,012       5,596  
Patents     61,954       131,652       167,789  
    $ 2,980,144     $ 4,917,287     $ 3,112,579  

 

 F-33 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

14. General and Administration Costs

 

   

Year ended

July 31,

 
    2020     2019     2018  
                   
Consulting (Note 10)   $ 193,720     $ 342,940     $ 515,960  
Insurance     19,012       16,000       20,867  
Amortization     18,741       18,743       16,894  
Professional fees (Note 10)     1,054,130       289,720       244,131  
Regulatory, filing and transfer agent fees     49,117       52,879       85,496  
Rent     25,827       15,576       15,081  
Shareholder communications     132,694       338,241       289,208  
Travel     2,607       48,103       46,251  
Wages and salaries (Note 10)     249,080       68,367       110,456  
Other     112,537       53,902       43,369  
    $ 1,857,465     $ 1,244,471     $ 1,387,713  

 

 

15. Commitments

 

The Company’s lease arrangement for office space in Berkeley, California ends in January 2021 and the lease commitment is on a monthly basis in the amount of $2,368 per month.

 

 F-34 
 

BriaCell Therapeutics Corp

Notes to the Consolidated Financial Statements

For the Years Ended July 31, 2020 and 2019

(Expressed in Canadian Dollars)

 

 

 

16. Events After the Reporting Period

 

a) On August 18, 2020, the Company issued 50,000 common shares to Sichenzia Ross Ference LLP or certain members or employees of Sichenzia Ross Ference LLP as compensation for legal services. The shares were valued at $7.48 per share.
   
b) On November 17, 2020 (the “Closing Date”), the Company closed a brokered private placement (the “Offering”) of an unsecured convertible debenture unit of the Company (the “Unit”) to a single subscriber, purchased at a price of $375,000, less an original discount of approximately 29.33%, for aggregate gross proceeds of $265,000.

 

The Unit is comprised of (A) $375,000 principal amount (“Principal Amount”) of a 5.0% convertible unsecured debenture of the Company (the “Debenture”), due on the earlier of (i) 5 years from the issue date; (ii) the Company receiving $2,000,000 or more by way of private placement or public offering; or (iii) such earlier date as the principal amount hereof may become due, subject to extension upon mutual agreement of the Company and the holder of the Debenture; and (B) 69,188 common share purchase warrants of the Company (“Warrants”).

 

The Debenture is convertible, at the option of the holder thereof, from the period beginning on May 16, 2021, until the repayment of the Debenture in full, into that number of common shares of the Company (“Common Shares”) computed on the basis of the principal amount of the Debenture divided by the conversion price of $5.42 per Common Share (the “Conversion Price”).

 

Each Warrant entitles the holder thereof to purchase one Common Share of the Company (each a “Warrant Share”) for a period of five (5) years from the Closing Date at a price of $5.42 per Warrant Share, subject to adjustment as set forth in the Warrants. Each Warrant may also be exercised by presentation and surrender of the Warrant to the Company with a written notice of the Subscriber’s intention to effect a cashless exercise.

 

The Debenture will bear interest at a rate of 5.0% per annum and the Debenture may be prepaid in full or in part by the Company during the initial 120 day period after issuance of the Debenture without penalty. After 120 days, and only if the Company elects to prepay the Debenture prior to November 16, 2021, the Company will be required to pay a cash prepayment penalty equal to 35% of the Principal Amount of the Debenture (the “Prepayment Penalty”). In the event of default on the Debenture, the interest rate will increase to 12% per annum and a cash penalty payment equal to 40% of the Principal Amount of the Debenture will be added to the Principal Amount of the Debenture (the “Default Penalty”); and the Principal Amount, any accrued and unpaid interest and any other amount owing pursuant the Debenture, including any Prepayment Penalty and/or Default Penalty outstanding at that time shall be accelerated, and shall become immediately due and payable at the option of the holder.

 

In consideration for the services rendered by ThinkEquity, a division of Fordham Financial Management, Inc. (the “Broker”), the Broker received a cash commission of $26,500 from the Company in connection with the Offering. As additional consideration, the Company also issued to the Broker 4,890 non-transferable compensation warrants (the “Compensation Warrants”). Each Compensation Warrant is exercisable to acquire one Common Share at an exercise price of $5.42 at any time in whole or in part for a period of five (5) years from the Closing Date.

 

 F-35 
   

 

Up to 3,268,765 Common Units

 

Up to 3,268,765 Pre-funded Units

 

 

 

 

PROSPECTUS

 

 

 

ThinkEquity

a division of Fordham Financial Management, Inc.

 

________, 2020

 

Through and including   , 2020 (the 25th day after the date of this offering), all dealers effecting transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to a dealer’s obligation to deliver a prospectus when acting as an underwriter and with respect to an unsold allotment or subscription.

 

 
 

 

ALTERNATE PAGES FOR SELLING SHAREHOLDER PROSPECTUS

 

The information in this prospectus is not complete and may be changed. The selling shareholder named in this prospectus may not sell these securities until the registration statement filed with the Securities and Exchange Commission is declared effective. This prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.

 

Subject to Completion, dated December 10, 2020

 

PROSPECTUS

 

50,000 Common Shares

 

The selling shareholder plans to sell an aggregate of up to 50,000 common shares.

 

The shares offered by this prospectus may be sold by the selling shareholder from time to time in the open market, through privately negotiated transactions or a combination of these methods, at market prices prevailing at the time of sale or at negotiated prices. By separate prospectus (the “IPO Prospectus”), we have registered an aggregate of up to 3,268,765 common units, each consisting of one common share and one warrant, each whole warrant exercisable for one common share, which we are offering for sale to the public through our underwriters, excluding any shares issuable upon the underwriters’ over-allotment option. The selling shareholder has expressed an intent not to sell shares prior to the closing of or concurrently with the public offering.

 

In the IPO Prospectus we are also offering an aggregate of up to 3,268,765 pre-funded units, each consisting of a pre-funded warrant to purchase one common share at an exercise price of US$0.01 per share and a warrant, to those purchasers, if any, whose purchase of common units would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common shares immediately following the consummation of the offering, in lieu of common units that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common shares.

 

We have applied to have our common shares and warrants listed on The Nasdaq Capital Market under the symbols “BCTX” and “BCTXW”, respectively, which listing is a condition to this offering. Nasdaq has informed us that it will not approve our listing if the per Common Unit offering price in the IPO Prospectus is less than US$4.25.

 

The distribution of the shares by the selling shareholder is not subject to any underwriting agreement. We will not receive any proceeds from the sale of the shares by the selling shareholder. We will bear all expenses of registration incurred in connection with this offering, but all selling and other expenses incurred by the selling shareholder will be borne by it.

 

We are an “emerging growth company” under the federal securities laws and have elected to be subject to reduced public company reporting requirements. An investment in our common shares may be considered speculative and involves a high degree of risk, including the risk of a substantial loss of your investment. See “Risk Factors” beginning on page 19 to read about the risks you should consider before buying our common shares. An investment in our common shares is not suitable for all investors.

 

Sales of our common shares registered in this prospectus and the IPO Prospectus will result in two offerings taking place concurrently.

 

You should rely only on the information contained in this prospectus and any prospectus supplement or amendment. We have not authorized anyone to provide you with different information. This prospectus may only be used where it is legal to sell these securities. The information in this prospectus is only accurate on the date of this prospectus, regardless of the time of any sale of securities.

 

NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED THESE SECURITIES OR PASSED UPON THE ADEQUACY OR ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

 

The date of this prospectus is , 2020

 

 
 

 

EXPLANATORY NOTE

 

Concurrent with this offering, the Company is registering up to 3,268,765 common shares and up to 3,268,765 pre-funded units in connection with an initial public offering of common units, each consisting of one common share and one warrant, each whole warrant exercisable for one common share, and pre-funded units, each consisting of one pre-funded warrant and one warrant, each whole warrant exercisable for one common share (excluding 324,645 common shares and/or pre-funded warrants which may be sold upon exercise of the underwriters’ over-allotment option). Sales by shareholders that purchased common shares from the initial public offering may reduce the price of our common shares, demand for our shares and, as a result, the liquidity of your investment.

 

SELLING SHAREHOLDER

 

This prospectus relates to the resale from time to time by the selling shareholder identified herein of up to an aggregate of 50,000 common shares (the “Resale Shares”).

 

The transactions by which the selling shareholder acquired its securities from us were exempt under the registration provisions of the Securities Act.

 

The Resale Shares referred to above are being registered to permit public sales of the Resale Shares, and the selling shareholder may offer the shares for resale from time to time pursuant to this prospectus. The selling shareholder may also sell, transfer or otherwise dispose of all or a portion of their shares in transactions exempt from the registration requirements of the Securities Act or pursuant to another effective registration statement covering those shares.

 

The table below sets forth certain information regarding the selling shareholder and the Resale Shares offered in this prospectus. The selling shareholder has had no material relationship with us within the past three years other than as described in the footnotes to the table below or as a result of its acquisition of our shares or other securities.

 

Beneficial ownership is determined in accordance with the rules of the SEC. The selling shareholder’s percentage of ownership of our outstanding shares in the table below is based upon 771,962 common shares issued and outstanding as of December 10, 2020.

 

Name of Selling shareholder  

Number of Shares of Common Shares Beneficially Owned Before this Offering(1)

   

Percentage of Common Shares Beneficially Owned Before this Offering

   

Shares of Common Shares Offered in this Offering

   

Shares of Common Shares Beneficially Owned After this Offering(2)

   

Percentage of Common Shares Beneficially Owned After this Offering(2)

 
Sichenzia Ross Ference LLP     50,000       0 %     50,000       0       0 %

 

  (1) Under applicable SEC rules, a person is deemed to beneficially own securities which the person has the right to acquire within 60 days through the exercise of any option or warrant or through the conversion of a convertible security. Also under applicable SEC rules, a person is deemed to be the “beneficial owner” of a security with regard to which the person directly or indirectly, has or shares (a) voting power, which includes the power to vote or direct the voting of the security, or (b) investment power, which includes the power to dispose, or direct the disposition, of the security, in each case, irrespective of the person’s economic interest in the security. To our knowledge, subject to community property laws where applicable, each person named in the table has sole voting and investment power with respect to the common shares shown as beneficially owned by such selling shareholder, except as otherwise indicated in the footnotes to the table.
     
  (2)

Represents the amount of shares that will be held by the selling shareholder after completion of this offering based on the assumptions that (a) all Resale Shares registered for sale by the registration statement of which this prospectus is part will be sold and (b) no other common shares are acquired or sold by the selling shareholder prior to completion of this offering. However, each selling shareholder may sell all, some or none of the Resale Shares offered pursuant to this prospectus and may sell other common shares that they may own pursuant to another registration statement under the Securities Act or sell some or all of their shares pursuant to an exemption from the registration provisions of the Securities Act, including under Rule 144.

 

 Alt-2 

 

 

PLAN OF DISTRIBUTION

 

The selling shareholder may, from time to time, sell any or all of its Resale Shares on any stock exchange, market or trading facility on which the shares are traded or in private transactions. If the Resale Shares are sold through underwriters, the selling shareholder will be responsible for underwriting discounts or commissions or agent’s commissions. The Resale Shares may be sold at prevailing market prices or privately negotiated prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale or at negotiated prices. The selling shareholder may use any one or more of the following methods when selling shares:

 

  ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
     
  block trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as principal to facilitate the transaction;
     
  purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
     
  an exchange distribution in accordance with the rules of the applicable exchange;
     
  privately negotiated transactions;
     
  settlement of short sales entered into after the effective date of the registration statement of which this prospectus is a part;
     
  in transactions through broker-dealers that agree with the selling shareholder to sell a specified number of such securities at a stipulated price per security;
     
  through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
     
  a combination of any such methods of sale; or
     
  any other method permitted pursuant to applicable law.

 

The selling shareholder may also sell shares under Rule 144 under the Securities Act, if available, rather than under this prospectus. In general, a person who has beneficially owned restricted common shares for at least six months, in the event we have been a reporting company under the Exchange Act for at least 90 days, would be entitled to sell such securities, provided that such person is not deemed to be an affiliate of ours at the time of sale or to have been an affiliate of ours at any time during the three months preceding the sale.

 

The selling shareholder may also engage in short sales against the box, puts and calls and other transactions in our securities or derivatives of our securities and may sell or deliver shares in connection with these trades.

 

Broker-dealers engaged by the selling shareholder may arrange for other broker-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the selling shareholder (or, if any broker-dealer acts as agent for the purchaser of shares, from the purchaser) in amounts to be negotiated. The selling shareholder do not expect these commissions and discounts to exceed what is customary in the types of transactions involved. Any profits on the Resale Shares by a broker-dealer acting as principal might be deemed to be underwriting discounts or commissions under the Securities Act. Discounts, concessions, commissions and similar selling expenses, if any, attributable to the sale of the Resale Shares will be borne by a selling shareholder. The selling shareholder may agree to indemnify any agent, dealer or broker-dealer that participates in transactions involving sales of the Resale Shares if liabilities are imposed on that person under the Securities Act.

 

In connection with the sale of the Resale Shares, the selling shareholder may enter into hedging transactions with broker-dealers, which may in turn engage in short sales of our common shares in the course of hedging in positions they assume. The selling shareholder may also sell Resale Shares short and deliver common shares covered by this prospectus to close out short positions and to return borrowed shares in connection with such short sales. The selling shareholder may also loan or pledge the Resale Shares to broker-dealers that in turn may sell such shares.

 

 Alt-3 

 

 

The selling shareholder may from time to time pledge or grant a security interest in some or all of the Resale Shares owned by it and, if it defaults in the performance of its secured obligations, the pledgees or secured parties may offer and sell the Resale Shares from time to time under this prospectus after we have filed an amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending the list of selling shareholder to include the pledgee, transferee or other successors in interest as selling shareholder under this prospectus.

 

The selling shareholder also may transfer the Resale Shares in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus and may sell the Resale Shares from time to time under this prospectus after we have filed an amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending the list of selling shareholder to include the pledgees, transferees or other successors in interest as selling shareholder under this prospectus. The selling shareholder also may transfer and donate the Resale Shares in other circumstances in which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

 

The selling shareholder and any broker-dealers or agents that are involved in selling the Resale Shares may be deemed to be an “Underwriter” within the meaning of the Securities Act in connection with such sales. In such event, any commissions paid, or any discounts or concessions allowed to, such broker-dealers or agents and any profit realized on the Resale Shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. At the time a particular offering of the Resale Shares is made, a prospectus supplement, if required, will be distributed which will set forth the aggregate amount of Resale Shares being offered and the terms of the offering, including the name or names of any broker-dealers or agents, any discounts, commissions and other terms constituting compensation from the selling shareholder and any discounts, commissions or concessions allowed or re-allowed or paid to broker-dealers. Under the securities laws of some states, the Resale Shares may be sold in such states only through registered or licensed brokers or dealers. In addition, in some states the Resale Shares may not be sold unless such shares have been registered or qualified for sale in such state or an exemption from registration or qualification is available and is complied with. There can be no assurance that the selling shareholder will sell any or all of the Resale Shares registered pursuant to the registration statement, of which this prospectus forms a part.

 

The selling shareholder has informed us that it does not have any agreement or understanding, directly or indirectly, with any person to distribute the Resale Shares. At the time of the purchase of the Resale Shares, it had no agreements, plans or understandings, directly or indirectly, with any person to distribute the securities.

 

We are required to pay all fees and expenses incident to the registration of the Resale Shares. We are not obligated to pay any of the expenses of any attorney or other advisor engaged by the selling shareholder.

 

If we are notified by the selling shareholder that any material arrangement has been entered into with a broker-dealer for the sale of the Resale Shares, we will file a post-effective amendment to the registration statement. If the selling shareholder uses this prospectus for any sale of the Resale Shares, it will be subject to the prospectus delivery requirements of the Securities Act.

 

The anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of the Resale Shares and activities of the selling shareholder, which may limit the timing of purchases and sales of any of the Resale Shares by the selling shareholder and any other participating person. Regulation M may also restrict the ability of any person engaged in the distribution of the Resale Shares to engage in passive market-making activities with respect to the Resale Shares. Passive market making involves transactions in which a market maker acts as both our underwriter and as a purchaser of our common shares in the secondary market. All of the foregoing may affect the marketability of the Resale Shares and the ability of any person or entity to engage in market-making activities with respect to the Resale Shares.

 

Once sold under the registration statement, of which this prospectus forms a part, the Resale Shares will be freely tradable in the hands of persons other than our affiliates.

 

 Alt-4 

 

 

USE OF PROCEEDS

 

We will not receive proceeds from sales of the Resale Shares made under this prospectus.

 

DETERMINATION OF OFFERING PRICE

 

The common shares may be sold at prevailing market prices or privately negotiated prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale or at negotiated prices. See “Plan of Distribution” above for more information.

 

LEGAL MATTERS

 

Certain legal matters in connection with this offering will be passed upon for us by Sichenzia Ross Ference LLP, New York, New York. The validity of the issuance of our common shares offered in this prospectus and certain other legal matters as to Canadian law will be passed upon for us by Bennett Jones LLP, Toronto, Canada. Sichenzia Ross Ference LLP, the selling shareholder, has been issued 50,000 restricted common shares stock of the Company as compensation for legal services.

 

 Alt-5 

 

 

PART II

 

INFORMATION NOT REQUIRED IN PROSPECTUS

 

Indemnification of Directors, Officers, Employees and Agents

 

Under the BCBCA, a company may indemnify: (i) a current or former director or officer of that company; (ii) a current or former director or officer of another corporation if, at the time such individual held such office, the corporation was an affiliate of the company, or if such individual held such office at the company’s request; or (iii) an individual who, at the request of the company, held, or holds, an equivalent position in another entity (an “indemnifiable person”) against all costs, charges and expenses, including an amount paid to settle an action or satisfy a judgment, reasonably incurred by him or her in respect of any civil, criminal, administrative or other legal proceeding or investigative action (whether current, threatened, pending or completed) in which he or she is involved because of that person’s position as an indemnifiable person, unless: (i) the individual did not act honestly and in good faith with a view to the best interests of such company or the other entity, as the case may be; or (ii) in the case of a proceeding other than a civil proceeding, the individual did not have reasonable grounds for believing that the individual’s conduct was lawful. A company cannot indemnify an indemnifiable person if it is prohibited from doing so under its articles or by applicable law. A company may pay, as they are incurred in advance of the final disposition of an eligible proceeding, the expenses actually and reasonably incurred by an indemnifiable person in respect of that proceeding only if the indemnifiable person has provided an undertaking that, if it is ultimately determined that the payment of expenses was prohibited, the indemnifiable person will repay any amounts advanced. Subject to the aforementioned prohibitions on indemnification, a company must, after the final disposition of an eligible proceeding, pay the expenses actually and reasonably incurred by an indemnifiable person in respect of such eligible proceeding if such indemnifiable person has not been reimbursed for such expenses, and was wholly successful, on the merits or otherwise, in the outcome of such eligible proceeding or was substantially successful on the merits in the outcome of such eligible proceeding. On application from an indemnifiable person, a court may make any order the court considers appropriate in respect of an eligible proceeding, including the indemnification of penalties imposed or expenses incurred in any such proceedings and the enforcement of an indemnification agreement. As permitted by the BCBCA, our articles require us to indemnify our directors and former directors (and such individual’s respective heirs and legal representatives) and permit us to indemnify any person to the extent permitted by the BCBCA.

 

Recent Sales of Unregistered Securities

 

In the prior three years, we have issued and sold the securities described below without registering the securities under the Securities Act. None of these transactions involved any underwriters’ underwriting discounts or commissions, or any public offering. We believe that each of the following issuances was exempt from registration under the Securities Act in reliance on Regulation S promulgated under the Securities Act regarding sales by an issuer in offshore transactions, Regulation D under the Securities Act, Rule 701 under the Securities Act or pursuant to Section 4(a)(2) of the Securities Act regarding transactions not involving a public offering.

 

On September 9, 2019 the Company completed non brokered private placement of 40,300 common shares at a price of $21 per common share for gross proceeds of $846,300.

 

On October 15, 2019, the Company completed non brokered private placement of 27,069 common shares at a price of $21 per common share for gross proceeds of $568,444.

 

On March 25, 2019 and April 1, 2019, the Company completed a non-brokered private placement on of 99,117 shares of the Company at a price of $30 per share for aggregate gross proceeds of $2,973,524 (net proceeds: $2,845,784). Included in the Private Placement were $500,000 from Jamieson Bondarenko, an insider of the Company

 

On February 26, 2019, BriaCell announced a non-brokered private placement financing of 16,667 common shares of the Company to Mr. Bondarenko at a price of $30 per common share for gross proceeds of $500,000. Upon closing of the Offering, Mr. Bondarenko had a beneficial ownership of an aggregate of 76,902 common shares, representing approximately 13.7% of the Company’s issued and outstanding common shares.

 

On March 27, 2018, the Company completed a non-brokered private placement (the “Non-Brokered Unit Offering”) of 144,408 units of the Company (the “Units”) at a price of $30 per Unit for aggregate gross proceeds of $4,332,232. Under the Non-Brokered Unit Offering, each Unit consists of one common share (each, a “March Common Share”) and one common share purchase warrant (each, a “March Warrant”). The March Warrants are valid for 36 months following the closing of the Non-Brokered Unit Offering and each March Warrant is exercisable for one March Common Share at an exercise price of $42.

 

Concurrent with the Non-Brokered Unit Offering, the Company also completed a brokered private placement for the purchase of 5.0% unsecured convertible notes (each, a “March Note”) in the principal amount of US$885,000 (the “March Note Offering”). Under the terms of securities purchase agreements dated March 8, 2018 between the Company and the purchasers of March Notes, each March Note is convertible at the option of the holder into (i) common shares of BriaCell for so long as the March Note is outstanding, at a fixed conversion price of $30 per March Common Share, for a period of nine months from the date of issuance, which may be extended by the applicable holder for up to six additional months at the holder’s sole option, and (ii) for each March Common Share resulting from the conversion, one March Warrant. The March Warrants are valid for 36 months from their issuance date and each March Warrant is exercisable for one March Common Share at an exercise price of $42.

 

 II-1 

 

 

In connection with the Non-Brokered Unit Offering and the Note Offering (together, the “March Offerings”), the Company paid commissions to certain participating dealers on a portion of funds raised. In respect of the March Note Offering, an aggregate cash commissions of $235,215 and an aggregate 8,711 broker warrants (the “Broker Warrants”) were paid. The compensation warrants issued in connection with the March Offerings are exercisable for one March Common Share at an exercise price of $42 for a period of 36 months from the issue date.

 

Officers and members of the Company’s board of directors, including BriaCell’s Chief Executive Officer, Chief Financial Officer and the board’s Chairman, participated in the NonBrokered Unit Offering.

 

During July 2018, certain noteholders converted $106,843 of the Notes into 3,561 shares and 3,561 warrants and during August 2018, an additional $117,437 of Notes were converted and as such, the Company issued 3,915 shares and 3,915 warrants. On September 17, 2018, the Company and the Noteholders agreement to extend the repayment date of the Convertible notes for an additional six month, to March 2019.

 

On March 9, 2017, the Company and the Company’s President and CEO, completed a non-brokered private placement financing of 18,707 units for aggregate gross proceeds to the Company in the amount of $1,346,900. Under the offering, each Unit consisted of one common share in the capital of the Company and one-half of one Common Share purchase warrant.

 

On August 2, 2017, the Company and the Company’s President and CEO completed a non-brokered private placement resulting in gross proceeds of $631,785. The non-brokered private placement involved the sale of 13,528 units at a price of $48.00 per unit. Each unit consisted of one common share in the capital of the Company.

 

On July 24, 2017, the Company entered into a definitive share exchange agreement between BriaCell Therapeutics Corp., or BTC, the Company’s US subsidiary, Sapientia Pharmaceuticals, or Sapientia, and all the shareholders of Sapientia. Pursuant to the terms of the share exchange agreement, BTC acquired from the Sapientia shareholders all of the issued and outstanding shares in the capital of Sapientia. As consideration, the Sapientia shareholders received an aggregate of 8,333 common shares in the capital of BriaCell on a pro-rata basis, which were issued on September 5, 2017. As part of the transaction, the Company acquired all rights, including composition of matter patents, and preclinical study data to a novel therapeutic technology platform, known as protein kinase C delta (PKCδ) inhibitors, which represents a unique, highly-targeted approach to treat cancer and to boost the immune system.

 

Exhibits and Financial Statement Schedules

 

(a) Exhibits:

 

The following exhibits are filed as part of this registration statement:

 

Exhibit   Description
     
1.1   Form of Underwriting Agreement
     
3.1*   Articles of BriaCell Therapeutics Corp, dated July 26, 2006
     
3.2*   Articles of BriaCell Therapeutics Corp, dated October 22, 2019
     
3.3*   Notice of Articles, dated November 25, 2014
     
3.4*   Notice of Articles, dated August 22, 2019
     
4.1*   Warrant Agent Agreement by and among the Company, Computershare Inc. and Computershare Trust Company, N.A., and Form of Warrant for Registered Offering
     
4.2*   Form of Pre-Funded Warrant
     
4.3*   Form of Underwriter’s Warrant
     

4.4

 

Unsecured Convertible Debenture, dated November 16, 2020

     

4.5

 

Form of Warrant, issued November 16, 2020

     
4.6   Form of Broker Warrant, issued November 16, 2020
     
10.1*   Stock Option Plan, dated November 25, 2014
     
10.2*   Service Agreement with UC Davis, dated June 11, 2015
     
10.3*   Employment Agreement with Markus Lacher, dated July 3, 2015

 

 II-2 

 

 

10.4*   Clinical Study Agreement with Cancer Insight, LLC, dated May 2, 2016
     
10.5*   Amendment #1 to Service Agreement with UC Davis, dated June 12, 2016
     
10.6*   Employment Agreement with Dr. William V. Williams, dated October 12, 2016
     
10.7*   Licensing Agreement between Faller & Williams Technology LLC and Sapientia Pharmaceuticals, Inc., dated March 16, 2017
     
10.8*   Master Services Agreement with KBI Biopharma, Inc., dated March 17, 2017
     
10.9*   Share Exchange Agreement, dated July 24, 2017
     
10.10*   Clinical Study Agreement with Cancer Insight, LLC, dated September 29, 2017
     
10.11*   Service Agreement with Colorado State University, dated October 16, 2017
     
10.12*   Accelerated Clinical Trial Agreement (St. Joseph Heritage Healthcare), dated January 26, 2018
     
10.13*   Accelerated Clinical Trial Agreement (Cancer Center of Kansas, P.A), dated April 23, 2018
     
10.14*   Amendment #2 to Service Agreement with UC Davis, dated August 27, 2018
     
10.15*   Amendment #1 to Accelerated Clinical Trial Agreement by and between Cancer Center of Kansas, P.A. and Cancer Insight, LLC, dated August 28, 2018
     
10.16*   Accelerated Clinical Trial Agreement (University of Miami), dated September 4, 2018
     
10.17*   Accelerated Clinical Trial Agreement (Providence Regional Medical Center Everett), dated September 27, 2018
     
10.18*   First Supplement to Clinical Study Agreement with Cancer Insight, LLC, dated October 18, 2018
     
10.19*   Amendment #1 to Services Agreement with Colorado State University, dated April 2, 2019
     
10.20*   Stem Cell Program Services Agreement with UC Davis, May 3, 2019
     
10.21*   Amendment #1 to Accelerated Clinical Trial Agreement (St. Joseph Heritage Healthcare), dated May 7, 2019
     
10.22*   HLA Typing Services Agreement with Histogenetics, dated October 3, 2019
     
10.23*   Procurement Agreement with Catalent Pharma Solutions, LLC, dated June 13, 2019
     
10.24*   Clinical Supply Services Agreement with Catalent Pharma Solutions, LLC, dated June 13, 2019
     
10.25*   Quality Agreement with Catalent Pharma Solutions, LLC, dated June 25, 2019
     
10.26*   Consulting Agreement with Gadi Levin, effective as of November 1, 2016
     
10.27*   Form of Subscription Agreement (Private Placement 2018)
     
10.28*   Form of Securities Purchase Agreement (February 2018)
     
10.29*   Form of Canadian Warrant Certificate (March 2018)
     
10.30*   Form of Common Stock Purchase Warrant (March 2018)
     
10.31*   Form of Finders Warrant Certificate (March 2018)
     
10.32*   Form of Note (March 2018)
     
10.33*   Form of U.S. Warrant Certificate (March 2018)
     
10.34*   Form of Subscription Agreement (February - March 2019)
     
10.35*   Form of Subscription Agreement (September 2019)
     
10.36*   Form of Subscription Agreement (October 2019)
     
10.37*   Loan Agreement, dated December 3, 2019
     
10.38*   Loan Agreement, dated January 27, 2020
     
10.39*   Extension of Loan Agreements, dated February 18, 2020
     
10.40*   Loan Agreement, dated February 20, 2020
     
10.41*   Master Services Agreement, dated February 27, 2020
     
10.42*   Extension of Loan Agreements, dated March 16, 2020
     
10.43*   Canada Emergency Business Account (CEBA) Credit Agreement
     
10.44  

Cooperative Research and Development Agreement, dated October 28, 2020

     
10.45  

Subscription Agreement, dated October 30, 2020

     
21.1*   List of Subsidiaries
     
23.1   Consent of MNP, LLP
     
24.1*   Power of Attorney.

 

* Previously filed.

 

 II-3 

 

 

Undertakings

 

The undersigned Registrant hereby undertakes to:

 

(a) file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement to:

 

(i) include any prospectus required by section 10(a)(3) of the Securities Act;

 

(ii) reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or together, represent a fundamental change in the information in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and

 

(iii) include any material information with respect to the plan of distribution not previously disclosed in this registration statement or any material change to such information in the registration statement.

 

(b) that, for the purpose of determining any liability under the Securities Act, each post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

(c) to file a post-effective amendment to remove from registration any of the securities that remain unsold at the end of the offering.

 

(d) that insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant, the Registrant has been advised that in the opinion of the SEC, such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registration of expenses incurred or paid by a director, officer or controlling person to the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

 

 II-4 

 

 

(e) that, for the purpose of determining liability under the Securities Act to any purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.

 

(f) that, for the purpose of determining liability of the Registrant under the Securities Act to any purchaser in the initial distribution of the securities, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the Registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

 

(i) any preliminary prospectus or prospectus of the Registrant relating to the offering filed pursuant to Rule 424;

 

(ii) any free writing prospectus relating to the offering prepared by or on behalf of the Registrant or used or referred to by the Registrant;

 

(iii) the portion of any other free writing prospectus relating to the offering containing material information about the Registrant or its securities provided by or on behalf of the Registrant; and

 

(iv) any other communication that is an offer in the offering made by the Registrant to the purchaser.

 

The undersigned Registrant hereby undertakes that:

 

1. For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b) (1) or (4) or 497(h) under the Securities Act of 1933 shall be deemed to be part of this registration statement as of the time it was declared effective.

 

2. For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

 II-5 

 

 

Signatures

 

Pursuant to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form F-1 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in West Vancouver, British Columbia on December 10, 2020.

 

  BRIACELL THERAPEUTICS CORP.
  (Registrant)
   
  By: /s/ William V. Williams
    Dr. William V. Williams
    Chief Executive Officer, President and Director
    (Principal Executive Officer)
   
  By: /s/ Gadi Levin
    Gadi Levin
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities and on the dates indicated:

 

SIGNATURE   TITLE   DATE
         
/s/ William V. Williams   Chief Executive Officer,  

December 10, 2020

Dr. William V. Williams   President and Director    
         
/s/ Gadi Levin   Chief Financial Officer (Principal  

December 10, 2020

Gadi Levin   Financial and Accounting Officer)    
         
/s/ Jamieson Bondarenko   Chairman of the Board of Directors  

December 10, 2020

Jamieson Bondarenko        
         
/s/ Vaughn C. Embro-Pantalony   Director  

December 10, 2020

Vaughn C. Embro-Pantalony        
         
/s/ Rebecca Taub    Director  

December 10, 2020

Rebecca Taub        
         
/s/ Charles Wiseman   Director  

December 10, 2020

Charles Wiseman        
         
/s/ Martin Schmieg   Director  

December 10, 2020

Martin Schmieg

       

 

* By: /s/ William V. Williams   Attorney in Fact  

December 10, 2020

  William V. Williams        

 

SIGNATURE OF AUTHORIZED REPRESENTATIVE IN THE UNITED STATES

 

Pursuant to the requirements of the Securities Act of 1933, the undersigned, the duly authorized representative in the United States of BriaCell Therapeutics Corp., has signed this registration statement on December 10, 2020.

 

Authorized U.S. Representative  
   
  /s/ William V. Williams  
Name: Dr. William V. Williams  
Title: Chief Executive Officer  

 

 II-6 

 

EX-1.1 2 ex1-1.htm

 

Exhibit 1.1

 

UNDERWRITING AGREEMENT

 

between

 

BRIACELL THERAPEUTICS CORP.

 

and

 

THINKEQUITY

 

A DIVISION OF FORDHAM FINANCIAL MANAGEMENT, INC.

 

as Representative of the Several Underwriters

 

   
 

 

BRIACELL THERAPEUTICS CORP.

 

UNDERWRITING AGREEMENT

 

Vancouver, British Columbia
t, 2020

 

ThinkEquity
A Division of Fordham Financial Management, Inc.

 

As Representative of the several Underwriters named on Schedule 1 attached hereto

17 State Street, 22nd Fl

New York, NY 10004

 

Ladies and Gentlemen:

 

The undersigned, BriaCell Therapeutics Corp., a corporation formed under the laws of the Province of British Columbia (collectively with its subsidiaries and affiliates, including, without limitation, all entities disclosed or described in the Registration Statement (as hereinafter defined) as being subsidiaries or affiliates of BriaCell Therapeutics Corp., (the “Company”), hereby confirms its agreement (this “Agreement”) with ThinkEquity, a division of Fordham Financial Management, Inc., (hereinafter referred to as the “Representative”) and with the other underwriters named on Schedule 1 hereto for which the Representative is acting as representative (the Representative and such other underwriters being collectively called the “Underwriters” or, individually, an “Underwriter”) as follows:

 

1. Purchase and Sale of Securities.

 

1.1 Firm Units.

 

1.1.1 Nature and Purchase of Firm Units.

 

(i) On the basis of the representations and warranties herein contained, but subject to the terms and conditions herein set forth, the Company agrees to issue and sell to the several Underwriters, an aggregate of t units (each, a “Firm Unit”), with each Firm Unit consisting of either: (A) one common share, with no par value per share, (each, a “Common Share”) and one warrant (each, a “Warrant”) to purchase one Common Share at an exercise price of $t (representing 125% of the per Class A Firm Unit (as defined below) offering price (the “Public Offering Price”) set forth on the cover page of the Prospectus (as defined in subsection 2.1.1 hereof)) for a period of five (5) years, subject to adjustment as provided in the Warrant (each, a “Class A Firm Unit”); or (B) one pre-funded warrant (each, a “Pre-Funded Warrant”) to purchase one Common Share at an exercise price of $0.01 until such time as the Pre-Funded Warrant is exercised in full, subject to adjustment as provided in the Pre-Funded Warrant and one Warrant (each, a “Class B Firm Unit”). The Common Shares referred to in this Section 1.1.1(i) are hereinafter referred to as the “Firm Shares”, the Warrants referred to in this Section 1.1.1(i) are hereinafter referred to as the “Firm Warrants” and the Pre-Funded Warrants referred to in this Section 1.1.1(i) are hereinafter referred to as the “Firm Pre-Funded Warrants.” No Class A Firm Units will be certificated, and the Firm Shares and the Firm Warrants comprising the Class A Firm Units will be separated immediately upon issuance. No Class B Firm Units will be certificated, and the Firm Pre-Funded Warrants and the Firm Warrants comprising the Class B Firm Units will be separated immediately upon issuance.

 

   
 

 

(ii) The Underwriters, severally and not jointly, agree to purchase from the Company the number of Firm Units, as set forth opposite their respective names on Schedule 1 attached hereto and made a part hereof at a purchase price of $t per Class A Firm Unit (representing 93% of the Public Offering Price), which purchase price will be allocated as $t per Firm Share and $0.00001 per Firm Warrant, and at a purchase price of $t per Class B Firm Unit (representing 93% of the Public Offering Price minus $0.01), which purchase price will be allocated as $t per Pre-Funded Warrant and $t per Firm Warrant. The Class A Firm Units are to be offered to the public at the Public Offering Price and the Class B Firm Units are to be offered to the public at the Public Offering Price less $0.01 (being the per share exercise price of a Pre-Funded Warrant).

 

1.1.2 Firm Units Payment and Delivery.

 

(i) Delivery and payment for the Firm Units shall be made at 9:30 a.m., Eastern time, on the second (2nd) Business Day following the effective date (the “Effective Date”) of the Registration Statement (as defined in Section 2.1.1 below) (or the third (3rd) Business Day following the Effective Date if the Registration Statement is declared effective after 4:01 p.m., Eastern time) or at such earlier time as shall be agreed upon by the Representative and the Company, at the offices of Clark Wilson LLP (“Representative Counsel”), 900 – 885 West Georgia Street, Vancouver, British Columbia V6C 3H1, Canada, or at such other place (or remotely by facsimile or other electronic transmission) as shall be agreed upon by the Representative and the Company. The hour and date of delivery and payment for the Firm Units is called the “Closing Date.”

 

(ii) Payment for the Firm Units shall be made on the Closing Date by wire transfer in federal (same day) funds, payable to the order of the Company upon delivery of the certificates (in form and substance satisfactory to the Underwriters) representing the Firm Units (or, except in the case of Pre-Funded Warrants, through the facilities of the Depository Trust Company (“DTC”)) for the account of the Underwriters. The Firm Units shall be registered in such name or names and in such authorized denominations as the Representative may request in writing prior to the Closing Date. The Company shall not be obligated to sell or deliver the Firm Units except upon tender of payment by the Representative for all of the Firm Units. The term “Business Day” means any day other than a Saturday, a Sunday or a legal holiday or a day on which banking institutions are authorized or obligated by law to close in New York, New York.

 

1.2 Over-allotment Option.

 

1.2.1 Option Securities. For the purposes of covering any over-allotments in connection with the distribution and sale of the Firm Units, the Company hereby grants to the Underwriters an option (the “Over-allotment Option”) to purchase, in the aggregate, up to t additional Common Shares and/or Pre-Funded Warrants to purchase Common Shares, representing 15% of the Firm Shares and Firm Pre-Funded Warrants sold in the offering from the Company (the “Option Shares” or “Option Pre-Funded Warrants,” as applicable) and/or up to t additional Warrants to purchase an aggregate of an additional t Common Shares, representing 15% of the Firm Warrants sold in the offering from the Company (the “Option Warrants”). The purchase price to be paid per Option Share or Option Pre-Funded Warrant shall be equal to the price per Firm Share or Firm Pre-Funded Warrant set forth in Section 1.1.1(ii) hereof and the purchase price to be paid per Option Warrant shall be equal to the price per Firm Warrant set forth in Section 1.1.1(ii) hereof. The Over-allotment Option is, at the Underwriters’ sole discretion, for Option Shares and Option Warrants together, Option Pre-Funded Warrants and Option Warrants together, solely Option Shares, Solely Option Pre-Funded Warrants, solely Option Warrants, or any combination thereof (each, an “Option Security” and collectively, the “Option Securities”). The Firm Units and the Option Securities are collectively referred to as the “Securities.” The Securities and the Underlying Common Shares (as defined below), are collectively referred to as the “Public Securities.” The Public Securities shall be issued directly by the Company and shall have the rights and privileges described in the Registration Statement, the Pricing Disclosure Package and the Prospectus. The Firm Warrants and the Option Warrants, if any, shall be issued pursuant to, and shall have the rights and privileges set forth in, a warrant agreement, dated on or before the Closing Date, between the Company and Computershare Inc. and its wholly-owned subsidiary, Computershare Trust Company, N.A., collectively as warrant agent (the “Warrant Agreement”). The certificate (the “Pre-Funded Warrant Certificate”) evidencing the Firm Pre-Funded Warrants and the Option Pre-Funded Warrants, if any, will be in the form attached hereto as Exhibit A. The offering and sale of the Public Securities is herein referred to as the “Offering”.

 

 - 2 - 
 

 

1.2.2 Exercise of Option. The Over-allotment Option granted pursuant to Section 1.2.1 hereof may be exercised by the Representative as to all (at any time) or any part (from time to time) of the Option Securities within 45 days after the Effective Date. The Underwriters shall not be under any obligation to purchase any Option Securities prior to the exercise of the Over-allotment Option. The Over-allotment Option granted hereby may be exercised by the giving of oral notice to the Company from the Representative, which must be confirmed in writing by overnight mail, email, facsimile or other electronic transmission setting forth the number of Option Securities to be purchased and the date and time for delivery of and payment for the Option Securities (the “Option Closing Date”), which shall not be later than one (1) full Business Days after the date of the notice or such other time as shall be agreed upon by the Company and the Representative, at the offices of Representative Counsel or at such other place (including remotely by facsimile, email or other electronic transmission) as shall be agreed upon by the Company and the Representative. If such delivery and payment for the Option Securities does not occur on the Closing Date, the Option Closing Date will be as set forth in the notice. Upon exercise of the Over-allotment Option with respect to all or any portion of the Option Securities, subject to the terms and conditions set forth herein, (i) the Company shall become obligated to sell to the Underwriters the number of Option Securities specified in such notice and (ii) each of the Underwriters, acting severally and not jointly, shall purchase that portion of the total number of Option Securities then being purchased as set forth in Schedule 1 opposite the name of such Underwriter, subject to such adjustments as the Representative, in its sole discretion, shall determine.

 

1.2.3 Payment and Delivery. Payment for the Option Securities shall be made on the Option Closing Date by wire transfer in federal (same day) funds, payable to the order of the Company upon delivery to the Representative of certificates (in form and substance satisfactory to the Representative) representing the Option Securities (or, except in the case of Pre-Funded Warrants, through the facilities of DTC) for the account of the Underwriters. The applicable number of Option Securities shall be registered in such name or names and in such authorized denominations as the Representative may request in writing prior to the Option Closing Date. The Company shall not be obligated to sell or deliver the Option Securities except upon tender of payment by the Representative for applicable Option Securities. An Option Closing Date may be simultaneous with, but not earlier than, the Closing Date; and in the event that such time and date are simultaneous with the Closing Date, the term “Closing Date” shall refer to the time and date of delivery of the Firm Units and the applicable Option Securities.

 

 - 3 - 
 

 

1.3 Representative’s Warrant.

 

1.3.1 Warrant Amount; Term. The Company hereby agrees to issue to the Representative (and/or its designees) on the Closing Date or Option Closing Date, as applicable, a five-year warrant (the “Representative’s Warrant”) for the purchase such number of Common Shares as is equal to 5.0% of the Firm Units and Option Securities issued on such Closing Date or Option Closing Date, as applicable. The Representative’s Warrant agreement, in the form attached hereto as Exhibit B (the “Representative’s Warrant Agreement”), shall be exercisable, in whole or in part, commencing on a date which is six (6) months after the Effective Date and expiring on the five-year anniversary of the Effective Date at an initial exercise price per Common Share of $t, being equal to 125% of the Public Offering Price of the Firm Units. The Representative’s Warrant and the Common Shares issuable upon exercise thereof are hereinafter referred to together as the “Representative’s Securities.” The Representative understands and agrees that there are significant restrictions pursuant to FINRA Rule 5110 against transferring the Representative’s Warrant and the Underlying Common Shares during the one hundred eighty (180) days after the Effective Date, and additional restrictions imposed on transferring the Representative’s Warrant while the Common Shares are listed on the TSX Venture Exchange (the “TSXV”) and by its acceptance thereof shall agree that: (A) the Representative shall not sell, transfer, assign, pledge or hypothecate the Representative’s Warrant, or any portion thereof, or be the subject of any hedging, short sale, derivative, put or call transaction that would result in the effective economic disposition of such securities for a period of one hundred eighty (180) days following the Effective Date to anyone other than (i) an Underwriter or a selected dealer in connection with the Offering, or (ii) a bona fide officer or partner of the Representative or of any such Underwriter or selected dealer; or as otherwise expressly permitted by FINRA Rule 5110(g), and only if any such transferee agrees to the foregoing lock-up restrictions; and (B) so long as the Common Shares are listed on the TSXV, the Representative shall not sell, transfer, assign, pledge or hypothecate the Representative’s Warrant, or any portion thereof, or be the subject of any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the securities, to anyone other than (i) an affiliate or employee (or an affiliate of such employee) of Fordham Financial Management, Inc. within the meaning of policies of the TSXV or (ii) an Underwriter or a selected dealer in connection with the Offering or an officer or partner thereof.

 

1.3.2 Delivery. Delivery of the Representative’s Warrant Agreement shall be made on the Closing Date or Option Closing Date, as applicable, and shall be issued in the name or names and in such authorized denominations as the Representative may request.

 

2. Representations and Warranties of the Company.

 

The Company represents and warrants to the Underwriters as of the Applicable Time (as defined below), and as of the Closing Date and as of each Option Closing Date, if any, as follows (unless otherwise indicated, and all references to the Company in this Section 2 shall refer to the Company and its subsidiaries):

 

2.1 Filing of Registration Statement.

 

2.1.1 Pursuant to the Securities Act. The Company has filed with the U.S. Securities and Exchange Commission (the “Commission”) a registration statement, and an amendment or amendments thereto, on Form F-1 (File No. 333-234292), including any related prospectus or prospectuses, for the registration of the Public Securities and the Representative’s Securities under the Securities Act of 1933, as amended (the “Securities Act”), which registration statement and amendment or amendments have been prepared by the Company in all material respects in conformity with the requirements of the Securities Act and the rules and regulations of the Commission under the Securities Act (the “Securities Act Regulations”) and will contain all material statements that are required to be stated therein in accordance with the Securities Act and the Securities Act Regulations. Except as the context may otherwise require, such registration statement, as amended, on file with the Commission at the time the registration statement became effective (including the Preliminary Prospectus (as defined below) included in the registration statement, financial statements, schedules, exhibits and all other documents filed as a part thereof or incorporated therein by reference and all information deemed to be a part thereof as of the Effective Date pursuant to paragraph (b) of Rule 430A of the Securities Act Regulations (the “Rule 430A Information”)), is referred to herein as the “Registration Statement.” If the Company files any registration statement pursuant to Rule 462(b) of the Securities Act Regulations, then after such filing, the term “Registration Statement” shall include such registration statement filed pursuant to Rule 462(b). The Registration Statement has been declared effective by the Commission on the date hereof.

 

 - 4 - 
 

 

Each prospectus used prior to the effectiveness of the Registration Statement, and each prospectus that omitted the Rule 430A Information that was used after such effectiveness and prior to the execution and delivery of this Agreement, is herein called a “Preliminary Prospectus.” The Preliminary Prospectus, subject to completion, dated t, 2020, that was included in the Registration Statement immediately prior to the Applicable Time is hereinafter called the “Pricing Prospectus.” The final prospectus in the form first furnished to the Underwriters for use in the Offering is hereinafter called the “Prospectus.” Any reference to the “most recent Preliminary Prospectus” shall be deemed to refer to the latest Preliminary Prospectus included in the Registration Statement.

 

Applicable Time” means TIME [a.m./p.m.], Eastern time, on the date of this Agreement.

 

Canadian Public Disclosure Documents” means all information filed by or on behalf of the Company since August 1, 2014 with the Canadian Securities Regulators of the Provinces of British Columbia and Alberta and available for public viewing on SEDAR;

 

Canadian Securities Laws” means collectively, all applicable securities laws in Canada and the respective rules and regulations made thereunder, together with applicable multilateral or national instruments, orders, rulings, policies, rules and other regulatory instruments issued or adopted (and published) by Canadian Securities Regulators;

 

Canadian Securities Regulators” means, collectively, the securities regulators or other securities regulatory authorities in Canada;

 

Issuer Free Writing Prospectus” means any “issuer free writing prospectus,” as defined in Rule 433 of the Securities Act Regulations (“Rule 433”), including without limitation any “free writing prospectus” (as defined in Rule 405 of the Securities Act Regulations) relating to the Public Securities that is (i) required to be filed with the Commission by the Company, (ii) a “road show that is a written communication” within the meaning of Rule 433(d)(8)(i), whether or not required to be filed with the Commission, or (iii) exempt from filing with the Commission pursuant to Rule 433(d)(5)(i) because it contains a description of the Public Securities or of the Offering that does not reflect the final terms, in each case in the form filed or required to be filed with the Commission or, if not required to be filed, in the form retained in the Company’s records pursuant to Rule 433(g).

 

Issuer General Use Free Writing Prospectus” means any Issuer Free Writing Prospectus that is intended for general distribution to prospective investors (other than a “bona fide electronic road show,” as defined in Rule 433 (the “Bona Fide Electronic Road Show”)), as evidenced by its being specified in Schedule 2-B hereto.

 

Issuer Limited Use Free Writing Prospectus” means any Issuer Free Writing Prospectus that is not an Issuer General Use Free Writing Prospectus.

 

Pricing Disclosure Package” means any Issuer General Use Free Writing Prospectus issued at or prior to the Applicable Time, the Pricing Prospectus and the information included on Schedule 2-A hereto, all considered together.

 

2.1.2 Pursuant to the Exchange Act. The Company has filed with the Commission a Form 8-A (File Number 000-t) providing for the registration pursuant to Section 12(b) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), of the Common Shares and the Warrants, which registration statement complies in all material respects with the Exchange Act. The registration of the Common Shares and the Warrants under the Exchange Act has been declared effective by the Commission on or prior to the date hereof. The Company has taken no action designed to, or likely to have the effect of, terminating the registration of the Common Shares and the Warrants under the Exchange Act, nor has the Company received any notification that the Commission is contemplating terminating such registration.

 

 - 5 - 
 

 

2.2 Stock Exchange Listing. The Company’s Common Shares are currently quoted on the OTCQB under the symbol “BCTXF” and are also listed on the TSXV under the symbol “BCT.V”. The Common Shares and the Warrants have been approved for listing on the Nasdaq Capital Market (the “Exchange”), subject to official notice of issuance, and the Company has taken no action designed to, or likely to have the effect of, delisting either the Common Shares or Warrants from the Exchange, or the Common Shares from the TSXV, nor has the Company received any notification that the Exchange or the TSXV is contemplating terminating either such listing or the Company is out of compliance with the listing or maintenance requirements of the Exchange or the TSXV.

 

2.3 Foreign Private Issuer. The Company is a “foreign private issuer” (as defined in Rule 405 under the Securities Act).

 

2.4 No Stop Orders, etc. Neither the Commission nor, to the Company’s knowledge, any state regulatory authority has issued any order preventing or suspending the use of the Registration Statement, any Preliminary Prospectus or the Prospectus or has instituted or, to the Company’s knowledge, threatened to institute, any proceedings with respect to such an order. The Company has complied with each request (if any) from the Commission for additional information.

 

2.5 Disclosures in Registration Statement.

 

2.5.1 Compliance with Securities Act and 10b-5 Representation.

 

(i) Each of the Registration Statement and any post-effective amendment thereto, at the time it became effective, complied in all material respects with the requirements of the Securities Act and the Securities Act Regulations. Each Preliminary Prospectus, including the prospectus filed as part of the Registration Statement as originally filed or as part of any amendment or supplement thereto, and the Prospectus, at the time each was filed with the Commission, complied in all material respects with the requirements of the Securities Act and the Securities Act Regulations. Each Preliminary Prospectus delivered to the Underwriters for use in connection with the Offering and the Prospectus was or will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T.

 

(ii) Neither the Registration Statement nor any amendment thereto, at its effective time, as of the Applicable Time, at the Closing Date or at any Option Closing Date, contained, contains or will contain an untrue statement of a material fact or omitted, omits or will omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading. No post-effective amendment to the Registration Statement reflecting any facts or events arising after the date thereof which represent, individually or in the aggregate, a fundamental change in the information set forth therein is required to be filed with the Commission. The press releases disseminated by the Company during the twelve months preceding the date of this Agreement taken as a whole do not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made and when made, not misleading.

 

 - 6 - 
 

 

(iii) The Pricing Disclosure Package, as of the Applicable Time, at the Closing Date or at any Option Closing Date, did not, does not and will not include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; and each Issuer Limited Use Free Writing Prospectus hereto does not conflict with the information contained in the Registration Statement, any Preliminary Prospectus, the Pricing Prospectus or the Prospectus, and each such Issuer Limited Use Free Writing Prospectus, as supplemented by and taken together with the Pricing Prospectus as of the Applicable Time, did not include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading; provided, however, that this representation and warranty shall not apply to statements made or statements omitted in reliance upon and in conformity with written information furnished to the Company with respect to the Underwriters by the Representative expressly for use in the Registration Statement, the Pricing Prospectus or the Prospectus or any amendment thereof or supplement thereto. The parties acknowledge and agree that such information provided by or on behalf of any Underwriter consists solely of the following disclosure contained in the “Underwriting” section of the Prospectus: the second sentence of the third paragraph regarding concessions and disclosure contained in the subsections entitled “Stabilization”, “Passive Market Making”, “Discretionary Accounts” and “Other Relationships” (the “Underwriters’ Information”); and

 

(iv) None of the Preliminary Prospectus, the Prospectus, or any amendment or supplement thereto (including any prospectus wrapper), as of their respective issue dates, at the time of any filing with the Commission pursuant to Rule 424(b), at the Closing Date or at any Option Closing Date, included, includes or will include an untrue statement of a material fact or omitted, omits or will omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided, however, that this representation and warranty shall not apply to the Underwriters’ Information.

 

2.5.2 Disclosure of Agreements. The agreements and documents described in the Registration Statement, the Pricing Disclosure Package and the Prospectus conform in all material respects to the descriptions thereof contained therein and there are no agreements or other documents required by the Securities Act and the Securities Act Regulations to be described in the Registration Statement, the Pricing Disclosure Package and the Prospectus or to be filed with the Commission as exhibits to the Registration Statement, that have not been so described or filed. Each agreement or other instrument (however characterized or described) to which the Company is a party or by which it is or may be bound or affected and (i) that is referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, or (ii) is material to the Company’s business, has been duly authorized and validly executed by the Company, is in full force and effect in all material respects and is enforceable against the Company and, to the Company’s knowledge, the other parties thereto, in accordance with its terms, except (x) as such enforceability may be limited by bankruptcy, insolvency, reorganization or similar laws affecting creditors’ rights generally, (y) as enforceability of any indemnification or contribution provision may be limited under the federal and state securities laws, and (z) that the remedy of specific performance and injunctive and other forms of equitable relief may be subject to the equitable defenses and to the discretion of the court before which any proceeding therefor may be brought. None of such agreements or instruments has been assigned by the Company, and neither the Company nor, to the Company’s knowledge, any other party is in default thereunder and, to the Company’s knowledge, no event has occurred that, with the lapse of time or the giving of notice, or both, would constitute a default thereunder. To the best of the Company’s knowledge, performance by the Company of the material provisions of such agreements or instruments will not result in a violation of any existing applicable law, rule, regulation, judgment, order or decree of any governmental or regulatory agency or court, domestic or foreign, having jurisdiction over the Company or any of its assets or business (each, a “Governmental Entity”), including, without limitation, those relating to environmental laws and regulations.

 

2.5.3 Prior Securities Transactions. Since August 1, 2016, no securities of the Company have been sold by the Company or by or on behalf of, or for the benefit of, any person or persons controlling, controlled by or under common control with the Company, except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Preliminary Prospectus.

 

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2.5.4 Regulations. The disclosures in the Registration Statement, the Pricing Disclosure Package and the Prospectus concerning the effects of federal, state, local and all foreign laws, rules and regulations relating to the Offering and the Company’s business as currently contemplated are correct in all material respects and no other such regulations are required to be disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus which are not so disclosed.

 

2.5.5 No Other Distribution of Offering Materials. The Company has not, directly or indirectly, distributed and shall not distribute any offering material in connection with the Offering other than any Preliminary Prospectus, the Prospectus and other materials, if any, permitted under the Securities Act and consistent with Section 3.2 below.

 

2.6 Changes After Dates in Registration Statement.

 

2.6.1 No Material Adverse Change. Since the respective dates as of which information is given in the Registration Statement, the Pricing Disclosure Package and the Prospectus, except as otherwise specifically stated therein: (i) there has been no event, occurrence or development that has had or that could reasonably be expected to result in a Material Adverse Effect (as defined below) and no material adverse change in the financial position or results of operations of the Company, nor any change or development that, singularly or in the aggregate, would involve a material adverse change or a prospective material adverse change, in or affecting the condition (financial or otherwise), results of operations, business, assets or prospects of the Company (a “Material Adverse Change”); (ii) there have been no material transactions entered into by the Company, other than as contemplated pursuant to this Agreement; and (iii) no officer or director of the Company has resigned from any position with the Company. The Company does not have pending before the Commission any request for confidential treatment of information. Except for the issuance of the Public Securities contemplated by this Agreement, no event, liability, fact, circumstance, occurrence or development has occurred or exists or is reasonably expected to occur or exist with respect to the Company or its businesses, prospects, properties, operations, assets or financial condition that would be required to be disclosed by the Company under applicable securities laws at the time this representation is made or deemed made that has not been publicly disclosed at least one Trading Day (as defined below) prior to the date that this representation is made.

 

Material Adverse Effect” means (i) a material adverse effect on the legality, validity or enforceability of this Agreement, the Pre-Funded Warrant Certificates, the Warrant Agreement or the Representative’s Warrant Agreement, (ii) a material adverse effect on the results of operations, assets, business, prospects or condition (financial or otherwise) of the Company or (iii) a material adverse effect on the Company’s ability to perform in any material respect on a timely basis its obligations under this Agreement, the Pre-Funded Warrant Certificates, the Warrant Agreement or the Representative’s Warrant Agreement. “Trading Day” means a day on which the Exchange is open for trading.

 

2.6.2 Recent Securities Transactions, etc. Subsequent to the respective dates as of which information is given in the Registration Statement, the Pricing Disclosure Package and the Prospectus, and except as may otherwise be indicated or contemplated herein or disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has not: (i) issued any securities (other than (x) grants under any share compensation plan and (y) shares issued upon exercise or conversion of options, warrants or convertible securities described in the Registration Statement, the Pricing Disclosure Package and the Prospectus) or incurred any liability or obligation, direct or contingent, for borrowed money; or (ii) declared or paid any dividend or made any other distribution on or in respect to its capital stock.

 

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2.6.3 Independent Accountants. To the knowledge of the Company, MNP LLP (the “Auditor”), whose report is filed with the Commission as part of the Registration Statement, the Pricing Disclosure Package and the Prospectus, is an independent registered public accounting firm as required by the Securities Act and the Securities Act Regulations and the Public Company Accounting Oversight Board. Except as may otherwise be disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Auditor has not, during the periods covered by the financial statements included in the Registration Statement, the Pricing Disclosure Package and the Prospectus, provided to the Company any non-audit services, as such term is used in Section 10A(g) of the Exchange Act. The Auditor is independent in accordance with the auditors’ rules of professional conduct of the Chartered Professional Accountants of British Columbia, are independent public accountants as required under the Canadian Securities Laws of the Provinces of British Columbia and Alberta and there has never been a reportable event (within the meaning of National Instrument 51-102 Continuous Disclosure Obligations) between the Company and the Auditor.

 

2.6.4 Financial Statements, etc. The financial statements, including the notes thereto and supporting schedules included in the Registration Statement, the Pricing Disclosure Package and the Prospectus, fairly present in all material respects the financial position and the results of operations of the Company at the dates and for the periods to which they apply; comply in all material respects with the applicable accounting requirements and rules and regulations of the Commission with respect thereto as in effect at the time of filing; and such financial statements have been prepared in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”), consistently applied throughout the periods involved (provided that unaudited interim financial statements are subject to year-end audit adjustments that are not expected to be material in the aggregate and do not contain all footnotes required by IFRS); and the supporting schedules included in the Registration Statement present fairly the information required to be stated therein. Except as included therein, no historical or pro forma financial statements are required to be included in the Registration Statement, the Pricing Disclosure Package or the Prospectus under the Securities Act or the Securities Act Regulations. The pro forma and pro forma as adjusted financial information and the related notes, if any, included in the Registration Statement, the Pricing Disclosure Package and the Prospectus have been properly compiled and prepared in accordance with the applicable requirements of the Securities Act and the Securities Act Regulations and present fairly the information shown therein, and the assumptions used in the preparation thereof are reasonable and the adjustments used therein are appropriate to give effect to the transactions and circumstances referred to therein. All disclosures contained in the Registration Statement, the Pricing Disclosure Package or the Prospectus regarding “non-GAAP financial measures” (as such term is defined by the rules and regulations of the Commission), if any, comply with Regulation G of the Exchange Act and Item 10 of Regulation S-K of the Securities Act, to the extent applicable. Each of the Registration Statement, the Pricing Disclosure Package and the Prospectus discloses all material off-balance sheet transactions, arrangements, obligations (including contingent obligations), and other relationships of the Company with unconsolidated entities or other persons that may have a material current or future effect on the Company’s financial condition, changes in financial condition, results of operations, liquidity, capital expenditures, capital resources, or significant components of revenues or expenses. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, (a) neither the Company nor any of its direct and indirect subsidiaries, including each entity disclosed or described in the Registration Statement, the Pricing Disclosure Package and the Prospectus as being a subsidiary of the Company (each, a “Subsidiary” and, collectively, the “Subsidiaries”), has incurred any material liabilities or obligations, direct or contingent, or entered into any material transactions other than in the ordinary course of business, (b) the Company has not declared or paid any dividends or made any distribution of any kind with respect to its capital stock, (c) there has not been any change in the capital stock of the Company, or any of its Subsidiaries, other than (i) grants under any share compensation plan, and (ii) common shares issued upon exercise or conversion of options, warrants, or convertible securities described in the Registration Statement, the Pricing Disclosure Package and the Prospectus), and (d) there has not been any Material Adverse Change in the Company’s long-term or short-term debt, and (e) the Company has not altered its method of accounting.

 

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2.6.5 Authorized Capital; Options, etc. The Company had, at the date or dates indicated in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the duly authorized, issued and outstanding capitalization as set forth therein. Based on the assumptions stated in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company will have on the Closing Date the adjusted share capitalization set forth therein. Except as set forth in, or contemplated by, the Registration Statement, the Pricing Disclosure Package and the Prospectus, on the Effective Date, as of the Applicable Time and on the Closing Date and any Option Closing Date, there will be no stock options, warrants, or other rights to purchase or otherwise acquire any authorized, but unissued Common Shares or any security convertible or exercisable into Common Shares, or any contracts or commitments to issue or sell Common Shares or any such options, warrants, rights or convertible securities (“Common Share Equivalent”). No individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind (a “Person”) has any right of first refusal, pre-emptive right, right of participation, or any similar right to participate in the transactions contemplated by this Agreement, the Pre-Funded Warrant Certificates, the Warrant Agreement or the Representative’s Warrant Agreement. The issuance and sale of the Public Securities will not obligate the Company to issue Common Shares or other securities to any Person (other than the Underwriters) and will not result in a right of any holder of securities of the Company to adjust the exercise, conversion, exchange or reset price under any of such securities. There are no shareholders agreements, voting agreements or other similar agreements with respect to the Company’s capital stock to which the Company is a party or, to the knowledge of the Company, between or among any of the Company’s shareholders.

 

2.7 Valid Issuance of Securities, etc.

 

2.7.1 Outstanding Securities. All issued and outstanding securities of the Company issued prior to the transactions contemplated by this Agreement have been duly authorized and validly issued and are fully paid and non-assessable and have been issued in compliance with all United States federal and state securities laws and all Canadian provincial securities laws; the holders thereof have no rights of rescission with respect thereto, and are not subject to personal liability by reason of being such holders; and none of such securities were issued in violation of the pre-emptive rights of any holders of any security of the Company or similar contractual rights granted by the Company. The authorized Common Shares and other securities of the Company to be outstanding upon consummation of the Offering conform in all material respects to all statements relating thereto contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus. The offers and sales of the outstanding Common Shares were at all relevant times either registered or qualified under the Securities Act, the applicable state securities or “blue sky” laws and the applicable Canadian provincial securities laws or, based in part on the representations and warranties of the purchasers of such Common Shares, exempt from such registration or qualification requirements. The description of the Company’s stock option, stock bonus and other stock plans or arrangements, and the options or other rights granted thereunder, as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, accurately and fairly present, in all material respects, the information required to be shown with respect to such plans, arrangements, options and rights.

 

2.7.2 Securities Sold Pursuant to this Agreement. The Public Securities and the Representative’s Securities have been duly authorized for issuance and sale and, when issued and paid for, will be validly issued, fully paid and non-assessable, free and clear of all liens imposed by the Company; the holders thereof are not and will not be subject to personal liability by reason of being such holders; the Public Securities and Representative’s Securities are not and will not be subject to the pre-emptive rights of any holders of any security of the Company or similar contractual rights granted by the Company; and all corporate action required to be taken for the authorization, issuance and sale of the Public Securities and Representative’s Securities has been duly and validly taken; the Common Shares issuable upon exercise of the Pre-Funded Warrants, the Warrants and the Representative’s Warrant (the “Underlying Common Shares”) have been duly authorized and reserved for issuance by all necessary corporate action on the part of the Company and when paid for and issued in accordance with the Pre-Funded Warrant Certificate, the Warrant Agreement and the Representative’s Warrant Agreement, as the case may be, such Underlying Common Shares will be validly issued, fully paid and non-assessable; the holders thereof are not and will not be subject to personal liability by reason of being such holders; and the Public Securities and Representative’s Securities conform in all material respects to all statements with respect thereto contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus.

 

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2.8 Registration Rights of Third Parties. No holders of any securities of the Company or any rights exercisable for or convertible or exchangeable into securities of the Company have the right to require the Company to register any such securities of the Company under the Securities Act or to include any such securities in a registration statement to be filed by the Company.

 

2.9 Validity and Binding Effect of Agreements. This Agreement, the Pre-Funded Warrant Certificates, the Warrant Agreement and the Representative’s Warrant Agreement have been duly and validly authorized by the Company, and, when executed and delivered, will constitute, the valid and binding agreements of the Company, enforceable against the Company in accordance with their respective terms, except: (i) as such enforceability may be limited by bankruptcy, insolvency, reorganization or similar laws affecting creditors’ rights generally; (ii) as enforceability of any indemnification or contribution provision may be limited under the federal and state securities laws; and (iii) that the remedy of specific performance and injunctive and other forms of equitable relief may be subject to the equitable defenses and to the discretion of the court before which any proceeding therefor may be brought.

 

2.10 No Conflicts, etc. The execution, delivery and performance by the Company of this Agreement, the Pre-Funded Warrant Certificates, the Warrant Agreement, the Representative’s Warrant Agreement and all ancillary documents, the consummation by the Company of the transactions herein and therein contemplated and the compliance by the Company with the terms hereof and thereof do not and will not, with or without the giving of notice or the lapse of time or both: (i) result in a material breach of, or conflict with any of the terms and provisions of, or constitute a material default under, or result in the creation, modification, termination or imposition of any lien, charge or encumbrance upon any property or assets of the Company or give to others any rights of termination, amendment, acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement, credit facility, debt or other instrument (evidencing a Company debt or otherwise) or other understanding pursuant to the terms of any agreement or instrument to which the Company is a party; (ii) result in any violation of the provisions of the Company’s Notice of Articles or Articles (as the same may be amended or restated from time to time, collectively, the “Charter”); or (iii) violate any existing applicable law, rule, regulation, judgment, order or decree of any Governmental Entity as of the date hereof.

 

2.11 Regulatory. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus: (i) the Company has not received notice from any Governmental Entity alleging or asserting noncompliance with any Applicable Regulations (as defined in clause (ii) below) or Authorizations (as defined in clause (iii) below); (ii) the Company is and has been in material compliance with federal, state, provincial or foreign statutes, laws, ordinances, rules and regulations applicable to the Company (collectively, “Applicable Regulations”); (iii) the Company possesses all licenses, certificates, approvals, clearances, consents, authorizations, qualifications, registrations, permits, and supplements or amendments thereto required by any such Applicable Regulations and/or to carry on its businesses as now conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such Authorizations; (iv) the Company has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Entity or third party alleging that any product, operation or activity is in violation of any Applicable Regulations or Authorizations or has any knowledge that any such Governmental Entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, has there been any material noncompliance with or violation of any Applicable Regulations by the Company that could reasonably be expected to require the issuance of any such communication or result in an investigation, corrective action, or enforcement action by any Governmental Entity; and (v) the Company has not received notice that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Entity has threatened or is considering such action. Neither the Company nor, to the Company’s knowledge, any of its directors, officers, employees or agents has been convicted of any crime under any Applicable Regulations.

 

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2.12 No Defaults; Violations. No material default exists in the due performance and observance of any term, covenant or condition of any material license, contract, indenture, mortgage, deed of trust, note, loan or credit agreement, or any other agreement or instrument evidencing an obligation for borrowed money, or any other material agreement or instrument to which the Company is a party or by which the Company may be bound or to which any of the properties or assets of the Company is subject. The Company is not (i) in violation of any term or provision of its Charter, or (ii) in violation of any franchise, license, permit, applicable law, rule, regulation, judgment or decree of any Governmental Entity.

 

2.13 Corporate Power; Licenses; Consents.

 

2.13.1 Conduct of Business. The Company has all requisite corporate power and authority, and has all necessary authorizations, approvals, orders, licenses, certificates and permits of and from all governmental regulatory officials and bodies that it needs as of the date hereof to conduct its business purpose as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus except for the absence of which would not reasonably be expected to have a Material Adverse Effect.

 

2.13.2 Transactions Contemplated Herein. The Company has all corporate power and authority to enter into this Agreement, the Pre-Funded Warrant Certificates, the Warrant Agreement and the Representative’s Warrant Agreement and to carry out the provisions and conditions hereof and thereof, and all consents, authorizations, approvals and orders required in connection therewith have been obtained and no further action is required by the Company, the Company’s Board of Directors (the “Board”) or its shareholders in connection herewith or therewith. No consent, authorization or order of, and no filing with, any court, government agency or other body is required for the valid issuance, sale and delivery of the Public Securities and the consummation of the transactions and agreements contemplated by this Agreement, the Pre-Funded Warrant Certificates, the Warrant Agreement and the Representative’s Warrant Agreement and as contemplated by the Registration Statement, the Pricing Disclosure Package and the Prospectus, except with respect to applicable securities laws, the rules and regulations of the Financial Industry Regulatory Authority, Inc. (“FINRA”) and the policies of the TSXV.

 

2.14 D&O Questionnaires. To the Company’s knowledge, all information contained in the questionnaires (the “Questionnaires”) completed by each of the Company’s directors and officers immediately prior to the Offering (the “Insiders”) as supplemented by all information concerning the Company’s directors and officers as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as well as in each applicable Lock-Up Agreement (as defined in Section 2.23 below), provided to the Underwriters, is true and correct in all material respects and the Company has not become aware of any information which would cause the information disclosed in the Questionnaires to become materially inaccurate and incorrect.

 

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2.15 Litigation; Governmental Proceedings. There is no action, suit, proceeding, inquiry, arbitration, investigation, litigation or governmental proceeding pending or, to the Company’s knowledge, threatened against, or involving the Company or, to the Company’s knowledge, any executive officer or director which has not been disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus or in connection with the Company’s listing application for the listing of the Public Securities on the Exchange, or which adversely affects or challenges the legality, validity or enforceability of this Agreement, the Pre-Funded Warrant Certificates, the Warrant Agreement, the Representative’s Warrant Agreement or the Public Securities.

 

2.16 Good Standing. The Company has been duly organized and is validly existing as a corporation and is in good standing under the laws of the Province of British Columbia as of the date hereof, and is duly qualified to do business and is in good standing in each other jurisdiction in which its ownership or lease of property or the conduct of business requires such qualification, except where the failure to qualify, singularly or in the aggregate, would not have or reasonably be expected to result in a Material Adverse Change.

 

2.17 Insurance. The Company carries or is entitled to the benefits of insurance, with reputable insurers, in such amounts and covering such risks which the Company believes are reasonably adequate, including, but not limited to, directors and officers insurance coverage at least equal to $5,000,000 and the Company has included each Underwriter as an additional insured party to the directors and officers insurance coverage and all such insurance is in full force and effect. The Company has no reason to believe that it will not be able (i) to renew its existing insurance coverage as and when such policies expire or (ii) to obtain comparable coverage from similar institutions as may be necessary or appropriate to conduct its business as now conducted and at a cost that would not result in a Material Adverse Change.

 

2.18 Transactions Affecting Disclosure to FINRA.

 

2.18.1 Finder’s Fees. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, there are no claims, payments, arrangements, agreements or understandings relating to the payment of a finder’s, consulting or origination fee by the Company or any Insider with respect to the sale of the Public Securities hereunder or any other arrangements, agreements or understandings of the Company or, to the Company’s knowledge, any of its shareholders that may affect the Underwriters’ compensation, as determined by FINRA.

 

2.18.2 Payments Within Twelve (12) Months. Except as disclosed to the Representative or as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has not made any direct or indirect payments (in cash, securities or otherwise) to: (i) any person, as a finder’s fee, consulting fee or otherwise, in consideration of such person raising capital for the Company or introducing to the Company persons who raised or provided capital to the Company; (ii) any FINRA member; or (iii) any person or entity that has any direct or indirect affiliation or association with any FINRA member, within the twelve (12) months prior to the Effective Date, other than the payment to the Underwriters as provided hereunder in connection with the Offering.

 

2.18.3 Use of Proceeds. None of the net proceeds of the Offering will be paid by the Company to any participating FINRA member or its affiliates, except as specifically authorized herein.

 

2.18.4 FINRA Affiliation. There is no (i) officer or director of the Company, (ii) to the Company’s knowledge, beneficial owner of 5% or more of any class of the Company’s securities or (iii) to the Company’s knowledge, beneficial owner of the Company’s unregistered equity securities which were acquired during the 180-day period immediately preceding the filing of the Registration Statement that is an affiliate or associated person of a FINRA member participating in the Offering (as determined in accordance with the rules and regulations of FINRA).

 

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2.18.5 Information. All information provided by the Company in its FINRA questionnaire to Representative Counsel specifically for use by Representative Counsel in connection with its Public Offering System filings (and related disclosure) with FINRA is true, correct and complete in all material respects.

 

2.19 Foreign Corrupt Practices Act. None of the Company and its Subsidiaries or, to the Company’s knowledge, any director, officer, agent, employee or affiliate of the Company and its Subsidiaries or any other person acting on behalf of the Company and its Subsidiaries, has, directly or indirectly, given or agreed to give any money, gift or similar benefit (other than legal price concessions to customers in the ordinary course of business) to any customer, supplier, employee or agent of a customer or supplier, or official or employee of any governmental agency or instrumentality of any government (domestic or foreign) or any political party or candidate for office (domestic or foreign) or other person who was, is, or may be in a position to help or hinder the business of the Company (or assist it in connection with any actual or proposed transaction) that (i) might subject the Company to any damage or penalty in any civil, criminal or governmental litigation or proceeding, (ii) if not given in the past, might have had a Material Adverse Change or (iii) if not continued in the future, might adversely affect the assets, business, operations or prospects of the Company. The Company has taken reasonable steps to ensure that its accounting controls and procedures are sufficient to cause the Company to comply in all material respects with the Foreign Corrupt Practices Act of 1977, as amended.

 

2.20 Compliance with OFAC. None of the Company and its Subsidiaries or, to the Company’s knowledge, any director, officer, agent, employee or affiliate of the Company and its Subsidiaries or any other person acting on behalf of the Company and its Subsidiaries, is currently subject to any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury (“OFAC”), and the Company will not, directly or indirectly, use the proceeds of the Offering hereunder, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other person or entity, for the purpose of financing the activities of any person currently subject to any U.S. sanctions administered by OFAC.

 

2.21 Money Laundering Laws. The operations of the Company and its Subsidiaries are and have been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money laundering statutes of all jurisdictions, the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any Governmental Entity (collectively, the “Money Laundering Laws”); and no action, suit or proceeding by or before any Governmental Entity involving the Company with respect to the Money Laundering Laws is pending or, to the best knowledge of the Company, threatened.

 

2.22 Officers’ Certificate. Any certificate signed by any duly authorized officer of the Company and delivered to the Representative or to Representative Counsel shall be deemed a representation and warranty by the Company to the Underwriters as to the matters covered thereby.

 

2.23 Lock-Up Agreements. Schedule 3 hereto contains a complete and accurate list of the Company’s officers and directors (collectively, the “Lock-Up Parties”). The Company has caused each of the Lock-Up Parties to deliver to the Representative an executed Lock-Up Agreement, in the form attached hereto as Exhibit C (the “Lock-Up Agreement”), prior to the execution of this Agreement.

 

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2.24 Subsidiaries. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has no direct or indirect subsidiaries or variable interest entities and does not hold any equity interests in any other entity. The Company owns, directly or indirectly, all of the capital stock or other equity interests of each Subsidiary free and clear of any lien, and all of the issued and outstanding shares of capital stock of each Subsidiary are validly issued and fully paid, non-assessable, and free of pre-emptive and similar rights to subscribe for or purchase shares. Except as may not reasonably result in a Material Adverse Effect, all direct and indirect Subsidiaries of the Company are duly organized and in good standing under the laws of the place of organization or incorporation, and each Subsidiary is in good standing in each jurisdiction in which its ownership or lease of property or the conduct of business requires such qualification and no proceeding has been instituted in any such jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or curtail such power and authority or qualification.

 

2.25 Related Party Transactions. There are no business relationships or related party transactions involving the Company or any of its Subsidiaries or any other person required to be described in the Registration Statement, the Pricing Disclosure Package and the Prospectus that have not been described as required.

 

2.26 Board of Directors. The Board is comprised of the persons set forth under the heading of the Pricing Prospectus and the Prospectus captioned “Directors, Executive Officers and Significant Employees.” The qualifications of the persons serving as Board members and the overall composition of the Board comply with the Exchange Act, the Exchange Act Regulations, the Sarbanes-Oxley Act of 2002 and the rules promulgated thereunder (the “Sarbanes-Oxley Act”) applicable to the Company and the listing rules of the Exchange. At least one member of the Audit Committee of the Board qualifies as an “audit committee financial expert,” as such term is defined under Regulation S-K and the listing rules of the Exchange. In addition, at least a majority of the persons serving on the Board qualify as “independent,” as defined under the listing rules of the Exchange.

 

2.27 Sarbanes-Oxley Compliance.

 

2.27.1 Disclosure Controls. The Company has developed and currently maintains disclosure controls and procedures that will comply with Rule 13a-15 or 15d-15 under the Exchange Act Regulations, and such controls and procedures are effective to ensure that all material information concerning the Company will be made known on a timely basis to the individuals responsible for the preparation of the Company’s Exchange Act filings and other public disclosure documents.

 

2.27.2 Compliance. The Company is, or at the Applicable Time and on the Closing Date will be, in material compliance with the provisions of the Sarbanes-Oxley Act applicable to it, and has implemented or will implement such programs and taken reasonable steps to ensure the Company’s future compliance (not later than the relevant statutory and regulatory deadlines therefor) with all of the material provisions of the Sarbanes-Oxley Act.

 

2.28 Accounting Controls. The Company and its Subsidiaries maintain systems of “internal control over financial reporting” (as defined under Rules 13a-15 and 15d-15 under the Exchange Act Regulations) that comply with the requirements of the Exchange Act and have been designed by, or under the supervision of, their respective principal executive and principal financial officers, or persons performing similar functions, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS, including, but not limited to, internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with IFRS and to maintain asset accountability; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any material weaknesses in its internal controls. The Company’s auditors and the Audit Committee of the Board have been advised of: (i) all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting which are known to the Company’s management and that have adversely affected or are reasonably likely to adversely affect the Company’ ability to record, process, summarize and report financial information; and (ii) any fraud known to the Company’s management, whether or not material, that involves management or other employees who have a significant role in the Company’s internal controls over financial reporting.

 

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2.29 No Investment Company Status. The Company is not and, after giving effect to the Offering and the application of the proceeds thereof as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, will not be, required to register as an “investment company,” as defined in the Investment Company Act of 1940, as amended.

 

2.30 No Labor Disputes. No labor dispute with the employees of the Company or any of its Subsidiaries exists or, to the knowledge of the Company, is imminent. To the knowledge of the Company, no executive officer of the Company is, or is now expected to be, in violation of any material term of any employment contract, confidentiality, disclosure or proprietary information agreement or non-competition agreement, or any other contract or agreement or any restrictive covenant in favor of any third party, and the continued employment of each such executive officer does not subject the Company to any liability with respect to any of the foregoing matters. The Company is in material compliance with all federal, state, provincial, local and foreign laws and regulations relating to employment and employment practices, terms and conditions of employment and wages and hours.

 

2.31 Employee Benefit Laws. The Company is not in violation of or has not received notice of any violation with respect to any federal, state, provincial or foreign law relating to discrimination in the hiring, promotion or pay of employees, nor any applicable federal, state, provincial or foreign wages and hours law, nor any state law precluding the denial of credit due to the neighborhood in which a property is situated, the violation of any of which could reasonably be expected to have a Material Adverse Change.

 

2.32 Intellectual Property.

 

2.32.1 Title, License or Right to Use. The Company and each of its Subsidiaries own, have valid and enforceable title to, license to, or otherwise have the right to use, all patents, patent applications, inventions, all rights, whether conveyed by operation of law or contract, to any an all inventions made by an employee working in the scope of his or her employment, trademarks, service marks, trade names, corporate names, trademark registrations, trademark applications, service mark registrations, logos, trade dress, designs, data, database rights, Internet domain names, websites, web content, copyrights, moral rights, works of authorship, licenses, proprietary information and know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information, systems or procedures), and all other worldwide intellectual property and proprietary rights, including registrations and applications for registration thereof (including all rights pertaining to the foregoing anywhere in the world, including rights arising under international treaties and conventions), and all common law rights to intellectual property and associated goodwill (collectively, “Intellectual Property”) necessary for the conduct of their respective businesses as currently conducted and as currently proposed to be conducted, or which are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus as being owned by or licensed to the Company or its Subsidiaries. Where the Company and its Subsidiaries owns the Intellectual Property (the “Owned Intellectual Property”), the Owned Intellectual Property is owned by the Company or its Subsidiaries as sole and exclusive owner with good, valid and marketable title thereto, free and clear of all encumbrances. Where the Company or its Subsidiaries license the Intellectual Property (the “Licensed Intellectual Property”), to the knowledge of the Company, the Company or its Subsidiaries have valid and enforceable licenses to use any the Licensed Intellectual Property used by it in connection with, and as required for business of the Company and its Subsidiaries. No licenses have been granted by the Company or its Subsidiaries for the Owned Intellectual Property, except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus.

 

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2.32.2 No Violation of Third Party Intellectual Property. The Company and its Subsidiaries’ conduct of their respective businesses as currently conducted does not, and, to its knowledge will not infringe, misappropriate or otherwise violate any Intellectual Property of any third party. The Intellectual Property of the Company has not been adjudged by a court of competent jurisdiction to be invalid or unenforceable, in whole or in part, and the Company is unaware of any facts which would form a reasonable basis for any such adjudication. To the knowledge of the Company, no Person has infringed, misappropriated or violated the Owned Intellectual Property nor does such Owned Intellectual Property infringe, misappropriate or violate the Intellectual Property of any third party. To the knowledge of the Company and its Subsidiaries, there is no application pending of any other Person which would or would potentially interfere with or infringe any Owned Intellectual Property. The Company and its Subsidiaries have not received any notice of any claim of infringement, misappropriation or conflict with any intellectual property rights of another, and the Company is unaware of any facts which would form a reasonable basis for any such notice or claim.To the Company’s knowledge, there are no third parties who have rights to any Intellectual Property, except for customary reversionary rights of third-party licensors with respect to Intellectual Property that is disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus as owned by or licensed to the Company or its Subsidiaries.

 

2.32.3 No Pending Action. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, there is no pending or, to the Company’s knowledge, threatened action, suit, proceeding or claim by others: (i) challenging the Company’s rights in or to any Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; (ii) challenging the validity, enforceability or scope of any Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; or (iii) asserting that the Company or its Subsidiaries infringe, misappropriate, or otherwise violate, or would, upon the commercialization of any product or service described in the Registration Statement, the Pricing Disclosure Package and the Prospectus as under development, infringe, misappropriate, or otherwise violate, any Intellectual Property rights of others, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim.

 

2.32.4 Compliance; No Material Defects. To the knowledge of the Company, the Company and its Subsidiaries have complied with the terms of each agreement pursuant to which Intellectual Property has been licensed to the Company or its Subsidiaries, except as may not reasonably result in a Material Adverse Effect, and all such agreements are in full force and effect. To the Company’s knowledge, there are no material defects in any of the patents or patent applications included in the Intellectual Property. All registrations, filings and actions necessary to preserve the rights of the Company and its Subsidiaries to its Owned Intellectual Property have been made or taken in accordance with the provisions of any applicable law, rule, regulation, judgment, order or decree of any Governmental Entity and all such Owned Intellectual Property is valid and subsisting, in compliance with any existing applicable law, rule, regulation, judgment, order or decree of any Governmental Entity (including payment of filing, examination and maintenance fees and proofs of use) and is not subject to any unpaid maintenance fees or taxes or actions.

 

2.32.5 Protection of Intellectual Property. The Company and its Subsidiaries have taken all measures, in accordance with sound industry practices, to protect, maintain and safeguard their Intellectual Property, including the execution of appropriate nondisclosure, confidentiality agreements and invention assignment agreements and invention assignments with their employees or service providers. All employees and other developers of Owned Intellectual Property have executed written contracts with the Company or its Subsidiaries which (i) protect the confidentiality of all Intellectual Property, (ii) effect the full and irrevocable assignment to the Company and its Subsidiaries of all of the Intellectual Property conceived or reduced to practice by them for the Company or its Subsidiaries; and (iii) provide that employees and developers have waived all their non-assignable rights (including moral rights) in such Intellectual Property in favor of the Company and its Subsidiaries.

 

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2.32.6 Employees. No employee of the Company or its Subsidiaries is in or has been in violation of any material term of any employment contract, patent disclosure agreement, invention assignment agreement, non-competition agreement, non-solicitation agreement, nondisclosure agreement, or any restrictive covenant to or with a former employer where the basis of such violation relates to such employee’s employment with the Company or its Subsidiaries, as applicable.

 

2.32.7 Duty of Candor and Good Faith. The duty of candor and good faith as required by the United States Patent and Trademark Office during the prosecution of the United States patents and patent applications within the Intellectual Property have been complied with; and in all foreign offices having similar requirements, all such requirements have been complied with. None of the Company owned Intellectual Property or technology (including information technology and outsourced arrangements) employed by the Company or its Subsidiaries has been obtained or is being used by the Company or its Subsidiary in violation of any contractual obligation binding on the Company or its Subsidiaries or any of their respective officers, directors or employees or otherwise in violation of the rights of any persons.

 

2.33 Trade Secrets. The Company and its Subsidiaries have taken reasonable and customary actions to protect their rights in and prevent the unauthorized use and disclosure of trade secrets and confidential business information (including confidential source code, ideas, research and development information, know-how, formulas, compositions, technical data, designs, drawings, specifications, research records, records of inventions, test information, financial, marketing and business data, customer and supplier lists and information, pricing and cost information, business and marketing plans and proposals) owned by the Company and its Subsidiaries, and, there has been no unauthorized use or disclosure of the trade secrets or confidential business information.

 

2.34 IT Assets. Except as could not reasonably be expected to have a Material Adverse Effect, (i) the computers, software, servers, networks, data communications lines, and other information technology systems owned, licensed, leased or otherwise used by the Company or its Subsidiaries (excluding any public networks) (collectively, the “IT Assets”) operate and perform as is necessary for the operation of the business of the Company and its Subsidiaries as currently conducted and as proposed to be conducted as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, and (ii) to the knowledge of the Company, such IT Assets are not infected by viruses, disabling code or other harmful code. The Company and its Subsidiaries have at all times implemented and maintained all industry standard controls, policies, procedures, and safeguards to maintain and protect their confidential information and the integrity, continuous operation, redundancy and security of all IT Assets and data (including all Personal Data (defined below) sensitive, confidential or regulated data used in connection with their businesses, and there have been no breaches, violations, outages or unauthorized uses of or accesses to same, except for those that have been remedied without material cost or liability or the duty to notify any other person, nor any incidents under internal review or investigations relating to the same.

 

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2.35 Data Privacy and Security Laws. The Company and its Subsidiaries are, and at all prior times were, in material compliance with all applicable state and federal data privacy and security laws and regulations in the United States, including without limitation the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) as amended by the Health Information Technology for Economic and Clinical Health Act, and all applicable provincial and federal data privacy and security laws and regulations in Canada, including without limitation the Personal Information Protection and Electronic Documents Act (S.C. 2000, c. 5) (“PIPEDA”); and the Company and its Subsidiaries have taken commercially reasonable actions to prepare to comply with, and have been and currently are in compliance with, the European Union General Data Protection Regulation (“GDPR”) (EU 2016/679) (collectively, the “Privacy Laws”). To ensure compliance with the Privacy Laws, the Company and its Subsidiaries have in place, comply with, and take appropriate steps reasonably designed to ensure compliance in all material respects with their policies and procedures relating to data privacy and security and the collection, storage, use, disclosure, handling, and analysis of Personal Data (the “Policies”). “Personal Data” means (i) a natural person’s name, street address, telephone number, e-mail address, photograph, social security number or tax identification number, driver’s license number, passport number, credit card number, bank information, or customer or account number; (ii) any information which would qualify as “personally identifying information” under the Federal Trade Commission Act, as amended; (iii) Protected Health Information as defined by HIPAA; (iv) “personal information”, “personal health information”. and “business contact information” as defined by PIPEDA; (v) “personal data” as defined by GDPR; and (vi) any other piece of information that allows the identification of such natural person, or his or her family, or permits the collection or analysis of any data related to an identified person’s health or sexual orientation. The Company and its Subsidiaries have at all times made all disclosures to users or customers required by applicable laws and regulatory rules or requirements, and none of such disclosures made or contained in any Policy have, to the knowledge of the Company, been inaccurate or in violation of any applicable laws and regulatory rules or requirements in any material respect. The Company further certifies that neither it nor any Subsidiary: (i) has received notice of any actual or potential liability under or relating to, or actual or potential violation of, any of the Privacy Laws, and has no knowledge of any event or condition that would reasonably be expected to result in any such notice; (ii) is currently conducting or paying for, in whole or in part, any investigation, remediation, or other corrective action pursuant to any Privacy Law; or (iii) is a party to any order, decree, or agreement that imposes any obligation or liability under any Privacy Law.

 

2.36 Taxes. Each of the Company and its Subsidiaries has filed all returns (as hereinafter defined) required to be filed with taxing authorities prior to the date hereof or has duly obtained extensions of time for the filing thereof. Each of the Company and its Subsidiaries has paid all taxes (as hereinafter defined) shown as due on such returns that were filed and has paid all taxes imposed on or assessed against the Company or such respective Subsidiary. The provisions for taxes payable, if any, shown on the financial statements filed with or as part of the Registration Statement are sufficient for all accrued and unpaid taxes, whether or not disputed, and for all periods to and including the dates of such consolidated financial statements. Except as disclosed in writing to the Underwriters, (i) no issues have been raised (and are currently pending) by any taxing authority in connection with any of the returns or taxes asserted as due from the Company or its Subsidiaries, and (ii) no waivers of statutes of limitation with respect to the returns or collection of taxes have been given by or requested from the Company or its Subsidiaries. The term “taxes” means all federal, state, local, foreign and other net income, gross income, gross receipts, sales, use, ad valorem, transfer, franchise, profits, license, lease, service, service use, withholding, payroll, employment, excise, severance, stamp, occupation, premium, property, windfall profits, customs, duties or other taxes, fees, assessments or charges of any kind whatever, together with any interest and any penalties, additions to tax or additional amounts with respect thereto. The term “returns” means all returns, declarations, reports, statements and other documents required to be filed in respect to taxes.

 

2.37 Employee Benefit Plan. The Company and its Subsidiaries have not established any “employee benefit plan” (as defined under the Employee Retirement Income Security Act of 1974, as amended, and the regulations and published interpretations thereunder (collectively, “ERISA”).

 

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2.38 Compliance with Laws. The Company: (A) is and at all times has been in compliance with all statutes, rules, or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”), except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change; (B) has not received any warning letter, untitled letter or other correspondence or notice from any other governmental authority alleging or asserting noncompliance with any Applicable Laws or any Authorizations; (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority or third party alleging that any product operation or activity is in violation of any Applicable Laws or Authorizations and has no knowledge that any such governmental authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that any governmental authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that any such governmental authority is considering such action; (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (G) has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, no third party has initiated, conducted or intends to initiate any such notice or action. The disclosure in the Registration Statement, the Pricing Disclosure Package and the Prospectus concerning the effects of federal, state, provincial, local and all foreign regulation in respect of the Company’s business are correct in all material respects.

 

2.39 Application of Takeover Provisions. The Company and the Board have taken all necessary action, if any, in order to render inapplicable any control share acquisition, business combination, poison pill (including any distribution under a rights agreement) or other similar anti-takeover provision under the Company’s Articles (or similar constating documents) or the laws of its jurisdiction of incorporation that is or could become applicable as a result of the Underwriters and the Company fulfilling their obligations or exercising their rights under this Agreement, the Pre-Funded Warrant Certificates, the Warrant Agreement, or the Representative’s Warrant Agreement.

 

2.40 Solvency. Based on the consolidated financial condition of the Company as of the Closing Date and as of each Option Closing Date, if any, after giving effect to the receipt by the Company of the proceeds from the sale of the Public Securities hereunder, (i) the fair and saleable value of the Company’s assets exceeds the amount that will be required to be paid on or in respect of the Company’s existing debts and other liabilities (including known contingent liabilities) as they mature, (ii) the Company’s assets do not constitute unreasonably small capital to carry on its business as now conducted and as proposed to be conducted including its capital needs taking into account the particular capital requirements of the business conducted by the Company, consolidated and projected capital requirements and capital availability thereof, and (iii) the current cash flow of the Company, together with the proceeds the Company would receive, were it to liquidate all of its assets, after taking into account all anticipated uses of the cash, would be sufficient to pay all amounts on or in respect of its liabilities when such amounts are required to be paid. The Company does not intend to incur debts beyond its ability to pay such debts as they mature (taking into account the timing and amounts of cash to be payable on or in respect of its debt). The Company has no knowledge of any facts or circumstances which lead it to believe that it will file for reorganization or liquidation under the bankruptcy or reorganization laws of any jurisdiction within one year from the Closing Date. The Registration Statement, Pricing Disclosure Package and the Prospectus set forth as of the date hereof all outstanding secured and unsecured Indebtedness (as defined below) of the Company for which the Company has commitments.

 

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Indebtedness” means (i) any liabilities for borrowed money or amounts owed in excess of $50,000 (other than trade accounts payable incurred in the ordinary course of business), (ii) all guaranties, endorsements and other contingent obligations in respect of indebtedness of others, whether or not the same are or should be reflected in the Company’s consolidated balance sheet (or the notes thereto), except guaranties by endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of business; and (iii) the present value of any lease payments in excess of $50,000 due under leases required to be capitalized in accordance with IFRS.

 

2.41 Ineligible Issuer. At the time of filing the Registration Statement and any post-effective amendment thereto, at the time of effectiveness of the Registration Statement and any amendment thereto, at the earliest time thereafter that the Company or another offering participant made a bona fide offer (within the meaning of Rule 164(h)(2) of the Securities Act Regulations) of the Public Securities and at the date hereof, the Company was and is an “ineligible issuer,” as defined in Rule 405, without taking account of any determination by the Commission pursuant to Rule 405 that it is not necessary that the Company be considered an ineligible issuer.

 

2.42 Real Property. Except as set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company and its Subsidiaries have good and marketable title in fee simple to, or have valid rights to lease or otherwise use, all items of real or personal property which are material to the business of the Company and its Subsidiaries taken as a whole, in each case free and clear of all liens, encumbrances, security interests, claims and defects that do not, singly or in the aggregate, materially affect the value of such property and do not interfere with the use made and proposed to be made of such property by the Company or its Subsidiaries; and all of the leases and subleases material to the business of the Company and its Subsidiaries, considered as one enterprise, and under which the Company or any of its Subsidiaries holds properties described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, are in full force and effect, and neither the Company nor any Subsidiary has received any notice of any material claim of any sort that has been asserted by anyone adverse to the rights of the Company or any Subsidiary under any of the leases or subleases mentioned above, or affecting or questioning the rights of the Company or such Subsidiary to the continued possession of the leased or subleased premises under any such lease or sublease.

 

2.43 Contracts Affecting Capital. There are no transactions, arrangements or other relationships between and/or among the Company, any of its affiliates (as such term is defined in Rule 405 of the Securities Act Regulations) and any unconsolidated entity, including, but not limited to, any structured finance, special purpose or limited purpose entity that could reasonably be expected to materially affect the Company’s or any of its Subsidiaries’ liquidity or the availability of or requirements for their capital resources required to be described or incorporated by reference in the Registration Statement, the Pricing Disclosure Package and the Prospectus which have not been described or incorporated by reference as required.

 

2.44 Loans to Directors or Officers. There are no outstanding loans, advances (except normal advances for business expenses in the ordinary course of business) or guarantees or indebtedness by the Company or its Subsidiaries to or for the benefit of any of the officers or directors of the Company, its Subsidiaries or any of their respective family members, except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus.

 

2.45 Reserved.

 

2.46 Industry Data. The statistical and market-related data included in each of the Registration Statement, the Pricing Disclosure Package and the Prospectus are based on or derived from sources that the Company reasonably and in good faith believes are reliable and accurate or represent the Company’s good faith estimates that are made on the basis of data derived from such sources.

 

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2.47 Consolidation/Reverse Share Split. The Company has taken all necessary corporate action to effectuate a consolidation, or reverse split, of its Common Shares on the basis of one (1) such share for each three hundred (300) issued and outstanding shares thereof (the “Consolidation”), such Consolidation became effective on January 2, 2020.

 

2.48 Emerging Growth Company. From the time of the initial confidential submission of the Registration Statement to the Commission (or, if earlier, the first date on which the Company engaged directly in or through any Person authorized to act on its behalf in any Testing-the-Waters Communication) through the date hereof, the Company has been and is an “emerging growth company,” as defined in Section 2(a) of the Securities Act (an “Emerging Growth Company”). “Testing-the-Waters Communication” means any oral or written communication with potential investors undertaken in reliance on Section 5(d) of the Securities Act.

 

2.49 Testing-the-Waters Communications. The Company has not (i) alone engaged in any Testing-the-Waters Communications, other than Testing-the-Waters Communications with the written consent of the Representative and with entities that are qualified institutional buyers within the meaning of Rule 144A under the Securities Act or institutions that are accredited investors within the meaning of Rule 501 under the Securities Act and (ii) authorized anyone other than the Representative to engage in Testing-the-Waters Communications. The Company confirms that the Representative has been authorized to act on its behalf in undertaking Testing-the-Waters Communications. The Company has not distributed any Written Testing-the-Waters Communications other than those listed on Schedule 2-C hereto. “Written Testing-the-Waters Communication” means any Testing-the-Waters Communication that is a written communication within the meaning of Rule 405 under the Securities Act.

 

2.50 Electronic Road Show. The Company has made available any Bona Fide Electronic Road Show in compliance with Rule 433(d)(8)(ii) of the Securities Act Regulations such that no filing of any “road show” (as defined in Rule 433(h) of the Securities Act Regulations) is required in connection with the Offering.

 

2.51 Margin Securities. The Company owns no “margin securities” as that term is defined in Regulation U of the Board of Governors of the Federal Reserve System (the “Federal Reserve Board”), and none of the proceeds of Offering will be used, directly or indirectly, for the purpose of purchasing or carrying any margin security, for the purpose of reducing or retiring any indebtedness which was originally incurred to purchase or carry any margin security or for any other purpose which might cause any of the Common Shares, Pre-Funded Warrants or Warrants to be considered a “purpose credit” within the meanings of Regulation T, U or X of the Federal Reserve Board.

 

2.52 Environmental Laws.

 

2.52.1 Compliance. The Company and its Subsidiaries are in compliance with all federal, state, and local laws and regulations relating to the use, treatment, storage and disposal of hazardous or toxic substances or waste and protection of health and safety or the environment which are applicable to their businesses (“Environmental Laws”).

 

2.52.2 Permits. The Company has all permits, authorizations and approvals required under any applicable Environmental Laws and is in compliance with their requirements.

 

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2.52.3 Hazardous Substances. There has been no storage, generation, transportation, handling, treatment, disposal, discharge, emission or other release of any kind of toxic or other wastes or other hazardous substances by, due to, or caused by the Company or any of its Subsidiaries (or, to the Company’s knowledge, any other entity for whose acts or omissions the Company or any of its Subsidiaries is or may otherwise be liable) upon any of the property now or previously owned or leased by the Company or any of its Subsidiaries, or upon any other property, in violation of any law, statute, ordinance, rule, regulation, order, judgment, decree or permit or which would, under any law, statute, ordinance, rule (including rule of common law), regulation, order, judgment, decree or permit, give rise to any liability, except for any violation or liability which would not have, singularly or in the aggregate with all such violations and liabilities, a Material Adverse Effect; and there has been no disposal, discharge, emission or other release of any kind in violation of Environmental Laws onto such property or into the environment surrounding such property of any toxic or other wastes or other hazardous substances with respect to which the Company has knowledge.

 

2.52.4 No Pending or Threatened Proceedings. There are no pending or, to the knowledge of the Company, threatened administrative, regulatory or judicial actions, suits, demands, demand letters, claims, liens, notices of non-compliance or violation, investigation or proceedings relating to any Environmental Laws against the Company.

 

2.52.5 No Basis for Action. There are no events or circumstances, to the knowledge of the Company, that would reasonably be expected to form the basis of an order for clean-up or remediation, or an action, suit or proceeding by any private party or Governmental Entity or against or affecting the Company relating to any Environmental Laws.

 

2.52.6 Periodic Review. In the ordinary course of business, the Company and its Subsidiaries conduct periodic reviews of the effect of Environmental Laws on their business and assets, in the course of which they identify and evaluate associated costs and liabilities (including, without limitation, any capital or operating expenditures required for clean-up, closure of properties or compliance with Environmental Laws or governmental permits issued thereunder, any related constraints on operating activities and any potential liabilities to third parties). On the basis of such reviews, the Company and its Subsidiaries have reasonably concluded that such associated costs and liabilities would not have, singularly or in the aggregate, a Material Adverse Effect.

 

2.53 Compliance with FTC, U.S. Department of Health and Human Services. There is no complaint to or audit, proceeding, investigation (formal or informal) or claim currently pending against the Company or its Subsidiaries, or to the knowledge of the Company, any of its customers (specific to the customer’s use of the products or services of the Company) by the Federal Trade Commission, the U.S. Department of Health and Human Services and any office contained therein (“HHS”), or any similar authority in any jurisdiction other than the United States or any other governmental entity, or by any person in respect of the collection, use or disclosure of Personal Data by the Company or its Subsidiaries, and, to the knowledge of the Company, no such complaint, audit, proceeding, investigation or claim is threatened.

 

2.54 Compliance with Health Care Laws. The Company and its Subsidiaries are, and at all times have been, in compliance in all material respects with all Health Care Laws (defined below). Neither the Company, any of its Subsidiaries, nor any of their respective officers, directors, employees or agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its Subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company, and to the Company’s knowledge, its Subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company, any of its Subsidiaries, nor, to the Company’s knowledge, any of their respective employees, officers, directors, or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Additionally, neither the Company, any of its Subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. or Canadian federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

 

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Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act and the regulations promulgated thereunder; (ii) all applicable federal, state, provincial, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286, 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, provincial, local or foreign laws or regulatory bodies; and (vi) all other local, state, provincial, federal, national, supranational and foreign laws, relating to the regulation of the Company or its Subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof.

 

2.55 FDA, Health Canada and Other Regulatory Authorities.

 

2.55.1 The Company holds all licenses, certificates, approvals and permits from all United States federal and state and Canadian federal and provincial, foreign and other regulatory authorities, including but not limited to the United States Food and Drug Administration (the “FDA”), and Health Canada (“HC”), and any foreign regulatory authorities performing functions similar to those performed by the FDA, and HC that are material to the conduct of the business of the Company or its Subsidiaries as such business is now conducted as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, all of which are valid and in full force and effect and there is no proceeding pending or, to the knowledge of the Company, threatened which may cause any such license, certificate, approval or permit to be withdrawn, cancelled, suspended or not renewed.

 

2.55.2 Nothing has come to the attention of the Company that has caused the Company to believe that the completed studies, tests, preclinical studies and clinical trials conducted by or on behalf of the Company and its Subsidiaries that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus were not conducted, in all material respects, in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company; or that the drug substances used in the clinical trials have not been manufactured, in all material respects, under “current good manufacturing practices”, when required, in the United States, Canada and other jurisdictions in which such clinical trials have been and are being conducted.

 

2.55.3 No filing or submission to the FDA, HC, or any other regulatory body, that was or is intended to be the basis for any approval of the Company’s products or product candidates, to the knowledge of the Company, contains any material omission or material false information.

 

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2.55.4 The Company is not in violation in any material respect, of any material law, order, rule, regulation, writ, injunction or decree of any court or governmental agency or body, applicable to the investigation of new drugs in humans and animals, including, but not limited to, those promulgated by the FDA, or HC.

 

2.56 Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company or its Subsidiaries were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all authorizations and applicable laws, including, without limitation, the Health Care Laws and the rules and regulations promulgated thereunder and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any notices or correspondence from the FDA or any governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.

 

2.57 Forward-Looking Statements. No forward-looking statement (within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act) contained in the Registration Statement, the Pricing Disclosure Package or the Prospectus has been made or reaffirmed without a reasonable basis or has been disclosed other than in good faith.

 

2.58 Export and Import Laws. The Company and, to the Company’s knowledge, each of its affiliates, and any director, officer, agent or employee of, or other person associated with or acting on behalf of the Company, has acted at all times in compliance in all material respects with applicable Export and Import Laws (as defined below) and there are no claims, complaints, charges, investigations or proceedings pending or expected or, to the knowledge of the Company, threatened between the Company or any of its Subsidiaries and any governmental authority under any Export or Import Laws. The term “Export and Import Laws” means the Arms Export Control Act, the International Traffic in Arms Regulations, the Export Administration Act of 1979, as amended, the Export Administration Regulations, and all other laws and regulations of the United States government regulating the provision of services to non-U.S. parties or the export and import of articles or information from and to the United States of America, and all similar laws and regulations of any foreign government regulating the provision of services to parties not of the foreign country or the export and import of articles and information from and to the foreign country to parties not of the foreign country.

 

2.59 Integration. Neither the Company, nor to its knowledge, any of its affiliates, nor any person acting on its or their behalf has, directly or indirectly, made any offers or sales of any security or solicited any offers to buy any security, under circumstances that would cause the Offering to be integrated with prior offerings by the Company for purposes of the Securities Act that would require the registration of any such securities under the Securities Act.

 

2.60 No Undisclosed Relationships. No relationship, direct or indirect, exists between or among the Company or any of its Subsidiaries, on the one hand, and the directors, officers, shareholders, customers, suppliers or other affiliates of the Company or any of its Subsidiaries, on the other, that is required by the Securities Act to be described in each of the Registration Statement and the Prospectus and that is not so described in such documents and in the Pricing Disclosure Package.

 

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2.61 Confidentiality and Non-Competition. To the Company’s knowledge, no director, officer, key employee or consultant of the Company is subject to any confidentiality, non-disclosure, non-competition agreement or non-solicitation agreement with any employer or prior employer that could reasonably be expected to materially affect his, her or its ability to be and act in his, her or its respective capacity of the Company or be expected to result in a Material Adverse Change.

 

2.62 Corporate Records. The corporate records of the Company have been made available to the Representative and Representative Counsel, and such corporate records accurately in all material respects reflect all transactions referred to in such records. There are no material transactions, agreements, dispositions or other actions of the Company that are not properly approved and/or accurately and fairly recorded in the corporate records of the Company, as applicable.

 

2.63 Stabilization. Neither the Company nor, to its knowledge, any of its employees, directors, officers, shareholders, agents or affiliates (without the consent of the Representative) has taken, directly or indirectly, any action designed to or that has constituted or that might reasonably be expected to cause or result in, under Regulation M of the Exchange Act, or otherwise, stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Public Securities.

 

2.64 Canadian Securities Laws.

 

2.64.1 The Company is a reporting issuer in the Provinces of British Columbia and Alberta, is not in default of any material requirement of the Canadian Securities Laws of the Province of British Columbia and Alberta and is not included on a list of defaulting reporting issuers maintained by the securities regulators of such jurisdictions.

 

2.64.2 The Company is in compliance in all material respects with its timely and continuous disclosure obligations under the Canadian Securities Laws of the Provinces of British Columbia and Alberta and the Company is not in default of its filings under, nor has it failed to file or publish any document required to be filed or published under the Canadian Securities Laws of the Provinces of British Columbia and Alberta and, without limiting the generality of the foregoing, there has not occurred any Material Adverse Change since the respective dates as of which information is given in the Canadian Public Disclosure Documents which has not been publicly disclosed on a non-confidential basis and the Company has not filed any confidential material change reports since the date of such statements which remain confidential as at the date hereof.

 

2.64.3 The Canadian Public Disclosure Documents contain no untrue statement of a material fact as at the dates thereof nor do they omit to state a material fact which, at the date thereof, was required to have been stated or was necessary to prevent a statement that was made from being false or misleading in the circumstances in which it was made and were prepared in accordance with and comply with Canadian Securities Laws.

 

2.64.4 There are no reports or information that, in accordance with the requirements of the Canadian Securities Regulators or Canadian Securities Laws, must be made publicly available in connection with the Offering that have not been made publicly available as required. There are no documents required to be filed with the Canadian Securities Regulators in connection with the Offering that have not been filed as required, other than the filing of the Registration Statement and any post-closing filings required to be made by the Company pursuant to the Canadian Securities Laws.

 

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3. Covenants of the Company. The Company covenants and agrees as follows:

 

3.1 Amendments to Registration Statement. The Company shall deliver to the Representative, prior to filing, any amendment or supplement to the Registration Statement or Prospectus proposed to be filed after the Effective Date and not file any such amendment or supplement to which the Representative shall reasonably object in writing.

 

3.2 United States Federal Securities Laws and Canadian Securities Laws.

 

3.2.1 Compliance. The Company shall comply with the requirements of Rule 430A of the Securities Act Regulations, and will notify the Representative promptly, and confirm the notice in writing, (i) when any post-effective amendment to the Registration Statement shall become effective or any amendment or supplement to the Prospectus shall have been filed; (ii) of the receipt of any comments from the Commission; (iii) of any request by the Commission for any amendment to the Registration Statement or any amendment or supplement to the Prospectus or for additional information; (iv) of the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or any post-effective amendment or of any order preventing or suspending the use of any Preliminary Prospectus or the Prospectus, or of the suspension of the qualification of the Public Securities and Representative’s Securities for offering or sale in any jurisdiction, or of the initiation or threatening of any proceedings for any of such purposes or of any examination pursuant to Section 8(d) or 8(e) of the Securities Act concerning the Registration Statement and (v) if the Company becomes the subject of a proceeding under Section 8A of the Securities Act in connection with the Offering of the Public Securities and Representative’s Securities. The Company shall effect all filings required under Rule 424(b) of the Securities Act Regulations, in the manner and within the time period required by Rule 424(b) (without reliance on Rule 424(b)(8)), and shall take such steps as it deems necessary to ascertain promptly whether the form of prospectus transmitted for filing under Rule 424(b) was received for filing by the Commission and, in the event that it was not, it will promptly file such prospectus. The Company shall comply with the requirements of Section 4 of BC Instrument 72-503 Distribution of Securities outside British Columbia with respect to the Offering made either to (i) a purchaser that is not resident in Canada or (ii) on or through the facilities of an exchange or market outside Canada and the Company or Underwriters have no reason to believe that the purchaser is resident in Canada. The Underwriters and the Company agree to conduct the Offering in such a manner so as not to require registration thereof or the filing of a registration statement or a prospectus or similar document in any jurisdiction, other than the United States of America. To the extent that the Company and the Underwriters agree in writing that Securities will be offered to residents of Canada on a private placement basis exempt from the prospectus requirements of Canadian Securities Laws, the Company shall comply with the requirements relating to the prospectus exemptions under the Canadian Securities Laws with respect to the Offering that is made to a purchaser that is resident in Canada and the Underwriters shall comply with all reasonable requests in connection with such offering made by the Company and in such written agreement. The Company shall use its best efforts to prevent the issuance of any stop order, prevention or suspension and, if any such order is issued, to obtain the lifting thereof at the earliest possible moment.

 

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3.2.2 Continued Compliance. The Company shall comply with the Securities Act, the Securities Act Regulations, the Exchange Act, the Exchange Act Regulations and the Canadian Securities Laws so as to permit the completion of the distribution of the Public Securities as contemplated in this Agreement, the Pre-Funded Warrant Certificates and the Warrant Agreement and in the Registration Statement, the Pricing Disclosure Package and the Prospectus. If at any time when a prospectus relating to the Public Securities is (or, but for the exception afforded by Rule 172 of the Securities Act Regulations (“Rule 172”), would be) required by the Securities Act to be delivered in connection with sales of the Public Securities, any event shall occur or condition shall exist as a result of which it is necessary, in the opinion of counsel for the Underwriters or for the Company, to (i) amend the Registration Statement in order that the Registration Statement will not include an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading; (ii) amend or supplement the Pricing Disclosure Package or the Prospectus in order that the Pricing Disclosure Package or the Prospectus, as the case may be, will not include any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein not misleading in the light of the circumstances existing at the time it is delivered to a purchaser or (iii) amend the Registration Statement or amend or supplement the Pricing Disclosure Package or the Prospectus, as the case may be, in order to comply with the requirements of the Securities Act or the Securities Act Regulations, the Company will promptly (A) give the Representative notice of such event; (B) prepare any amendment or supplement as may be necessary to correct such statement or omission or to make the Registration Statement, the Pricing Disclosure Package or the Prospectus comply with such requirements and, a reasonable amount of time prior to any proposed filing or use, furnish the Representative with copies of any such amendment or supplement and (C) file with the Commission any such amendment or supplement; provided that the Company shall not file or use any such amendment or supplement to which the Representative or Representative Counsel shall reasonably object. The Company will furnish to the Underwriters such number of copies of such amendment or supplement as the Underwriters may reasonably request. The Company has given the Representative notice of any filings made pursuant to the Exchange Act or the Exchange Act Regulations within 48 hours prior to the Applicable Time. The Company shall give the Representative notice of its intention to make any such filing from the Applicable Time until the later of the Closing Date and the exercise in full or expiration of the Over-allotment Option specified in Section 1.2 hereof and will furnish the Representative with copies of the related document(s) a reasonable amount of time prior to such proposed filing, as the case may be, and will not file or use any such document to which the Representative or Representative Counsel shall reasonably object.

 

3.2.3 Exchange Act Registration. Until the later of (i) three (3) years after the date of this Agreement and (ii) the expiration date of the Pre-Funded Warrants and Warrants (or the date that all of the Pre-Funded Warrants and Warrants have been exercised or duly called, if earlier), the Company shall use its best efforts to maintain the registration of the Common Shares and Warrants under the Exchange Act. During such period, the Company shall not deregister the Common Shares or Warrants under the Exchange Act without the prior written consent of the Representative.

 

3.2.4 Free Writing Prospectuses. The Company agrees that, unless it obtains the prior written consent of the Representative, it shall not make any offer relating to the Public Securities that would constitute an Issuer Free Writing Prospectus or that would otherwise constitute a “free writing prospectus,” or a portion thereof, required to be filed by the Company with the Commission or retained by the Company under Rule 433; provided that the Representative shall be deemed to have consented to each Issuer General Use Free Writing Prospectus hereto and any “road show that is a written communication” within the meaning of Rule 433(d)(8)(i) that has been reviewed and approved in writing by the Representative. The Company represents that it has treated or agrees that it will treat each such free writing prospectus consented to, or deemed consented to, by the Underwriters as an “issuer free writing prospectus,” as defined in Rule 433, and that it has complied and will comply with the applicable requirements of Rule 433 with respect thereto, including timely filing with the Commission where required, legending and record keeping. If at any time following issuance of an Issuer Free Writing Prospectus there occurred or occurs an event or development as a result of which such Issuer Free Writing Prospectus conflicted or would conflict with the information contained in the Registration Statement or included or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances existing at that subsequent time, not misleading, the Company will promptly notify the Underwriters and will promptly amend or supplement, at its own expense, such Issuer Free Writing Prospectus to eliminate or correct such conflict, untrue statement or omission.

 

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3.2.5 Testing-the-Waters Communications. If at any time following the distribution of any Written Testing-the-Waters Communication there occurred or occurs an event or development as a result of which such Written Testing-the-Waters Communication included or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances existing at that subsequent time, not misleading, the Company shall promptly notify the Representative and shall promptly amend or supplement, at its own expense, such Written Testing-the-Waters Communication to eliminate or correct such untrue statement or omission.

 

3.3 Delivery to the Underwriters of Registration Statements. The Company has delivered or made available or shall deliver or make available to the Representative and Representative Counsel, without charge, signed copies of the Registration Statement as originally filed and each amendment thereto (including exhibits filed therewith) and signed copies of all consents and certificates of experts, and will also deliver to the Underwriters, without charge, a conformed copy of the Registration Statement as originally filed and each amendment thereto (without exhibits) for each of the Underwriters. The copies of the Registration Statement and each amendment thereto furnished to the Underwriters will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T.

 

3.4 Delivery to the Underwriters of Prospectuses. The Company has delivered or made available or will deliver or make available to each Underwriter, without charge, as many copies of each Preliminary Prospectus as such Underwriter reasonably requested, and the Company hereby consents to the use of such copies for purposes permitted by the Securities Act. The Company will furnish to each Underwriter, without charge, during the period when a prospectus relating to the Public Securities is (or, but for the exception afforded by Rule 172, would be) required to be delivered under the Securities Act, such number of copies of the Prospectus (as amended or supplemented) as such Underwriter may reasonably request. The Prospectus and any amendments or supplements thereto furnished to the Underwriters will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T. Neither the Company nor any of its directors and officers has distributed and none of them will distribute, prior to the Closing Date or Option Closing Date, as applicable, any offering material in connection with the offering and sale of the Public Securities other than the Prospectus, the Registration Statement, and copies of the documents incorporated by reference therein.

 

3.5 Effectiveness and Events Requiring Notice to the Representative. The Company shall use its best efforts to cause the Registration Statement to remain effective with a current prospectus through and including the expiration date of the Pre-Funded Warrants and Warrants (or the date that all of the Pre-Funded Warrants and Warrants have been exercised or duly called, if earlier), and shall notify the Representative immediately and confirm the notice in writing: (i) of the effectiveness of the Registration Statement and any amendment thereto; (ii) of the issuance by the Commission of any stop order or of the initiation, or the threatening, of any proceeding for that purpose; (iii) of the issuance by any state securities commission of any proceedings for the suspension of the qualification of the Public Securities for offering or sale in any jurisdiction or of the initiation, or the threatening, of any proceeding for that purpose; (iv) of the issuance by any Canadian Securities Regulator of an order ceasing or suspending trading in any securities of the Company, or ceasing or suspending trading by the directors, officers or shareholders of the Company, or any one of them, or prohibiting the trade or distribution of any of the securities referred to herein (the “Cease Trade Order”); (v) of the mailing and delivery to the Commission for filing of any amendment or supplement to the Registration Statement or Prospectus; (vi) of the receipt of any comments or request for any additional information from the Commission; and (vii) of the happening of any event during the period described in this Section 3.5 that, in the judgment of the Company, makes any statement of a material fact made in the Registration Statement, the Pricing Disclosure Package or the Prospectus untrue or that requires the making of any changes in (a) the Registration Statement in order to make the statements therein not misleading, or (b) in the Pricing Disclosure Package or the Prospectus in order to make the statements therein, in light of the circumstances under which they were made, not misleading. If the Commission or any state securities commission shall enter a stop order or suspend such qualification at any time, the Company shall make every reasonable effort to obtain promptly the lifting of such order. If any Canadian Securities Regulator shall enter an order ceasing or suspending trading in any securities of the Company at any time, the Company shall make every reasonable effort to obtain promptly the lifting of such order.

 

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3.6 Review of Financial Statements. For a period of five (5) years after the date of this Agreement, the Company, at its expense, shall cause its regularly engaged independent registered public accounting firm to review (but not audit) the Company’s interim financial statements for each of the three fiscal quarters that are not its fourth fiscal quarter immediately preceding the announcement of any quarterly financial information.

 

3.7 Listing. The Company shall use its best efforts to maintain the listing of the Common Shares and Warrants on the Exchange until the later of (i) three (3) years after the date of this Agreement and (ii) the expiration date of the Pre-Funded Warrants and Warrants (or the date that all of the Pre-Funded Warrants and Warrants have been exercised or duly called, if earlier). The Company shall use its best efforts to maintain the listing of the Common Shares on the TSXV for at least three (3) years from the date of this Agreement.

 

3.8 Financial Public Relations Firm. As of the Effective Date, the Company shall have retained a financial public relations firm reasonably acceptable to the Representative and the Company, which shall initially be t, which firm shall be experienced in assisting issuers in initial public offerings of securities and in their relations with their security holders, and shall retain such firm or another firm reasonably acceptable to the Representative for a period of not less than two (2) years after the Effective Date.

 

3.9 Research Independence. In addition, the Company acknowledges that each Underwriter’s research analysts and research departments, if any, are required to be independent from their respective investment banking divisions and are subject to certain regulations and internal policies, and that such Underwriter’s research analysts may hold and make statements or investment recommendations and/or publish research reports with respect to the Company and/or the offering that differ from the views of its investment bankers. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against such Underwriter with respect to any conflict of interest that may arise from the fact that the views expressed by their independent research analysts and research departments may be different from or inconsistent with the views or advice communicated to the Company by such Underwriter’s investment banking divisions. The Company acknowledges that the Representative is a full service securities firm and as such from time to time, subject to applicable securities laws, may effect transactions for its own account or the account of its customers and hold long or short position in debt or equity securities of the Company.

 

3.10 Reports to the Representative, Transfer Agent and Warrant Agent.

 

3.10.1 Periodic Reports, etc. For a period of three (3) years after the date of this Agreement, the Company shall furnish or make available to the Representative copies of such financial statements and other periodic and special reports as the Company from time to time furnishes generally to holders of any class of its securities and also promptly furnish to the Representative: (i) a copy of each annual report on From 20-F the Company shall be required to file with the Commission under the Exchange Act and the Exchange Act Regulations; (ii) a copy of every press release and every news item and article with respect to the Company or its affairs which was released by the Company; (iii) a copy of each report on Form 6-K the Company shall be required to furnish to the Commission under the Exchange Act and the Exchange Act Regulations; (iv) five copies of each registration statement filed by the Company under the Securities Act; and (v) such additional documents and information with respect to the Company and the affairs of any future subsidiaries of the Company as the Representative may from time to time reasonably request; provided the Representative shall sign, if requested by the Company, a Regulation FD compliant confidentiality agreement which is reasonably acceptable to the Representative and Representative Counsel in connection with the Representative’s receipt of such information. Documents filed with the Commission pursuant to its EDGAR system shall be deemed to have been delivered to the Representative pursuant to this Section 3.10.1.

 

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3.10.2 Transfer Agent; Warrant Agent; Transfer Sheets. Until the later of (i) three (3) years after the date of this Agreement and (ii) the expiration date of the Pre-Funded Warrants and Warrants (or the date that all of the Pre-Funded Warrants and Warrants have been exercised or duly called, if earlier), the Company shall retain a transfer agent and registrar acceptable to the Representative (the “Transfer Agent”) and a warrant agent (the “Warrant Agent”) and shall furnish to the Representative at the Company’s sole cost and expense such transfer sheets of the Company’s securities as the Representative may reasonably request, including the daily and monthly consolidated transfer sheets of the Transfer Agent, the Warrant Agent and DTC. Computershare Investor Services Inc. is acceptable to the Representative to act as Transfer Agent for the Common Shares and Computershare Inc. and its wholly-owned subsidiary, Computershare Trust Company, N.A., collectively, is acceptable to the Representative to act as Warrant Agent for the Warrants.

 

3.10.3 Trading Reports. During such time as the Public Securities are listed on the Exchange, the Company shall provide to the Representative, at the Company’s expense, such reports published by Exchange relating to price trading of the Public Securities, as the Representative shall reasonably request.

 

3.11 Payment of Expenses.

 

3.11.1 General Expenses Related to the Offering. The Company hereby agrees to pay on each of the Closing Date and the Option Closing Date, if any, to the extent not previously paid, including the Advance (as such term is defined in Section 8.3 hereof), all expenses incident to the performance of the obligations of the Company under this Agreement, including, but not limited to: (a) all filing fees and communication expenses relating to the registration of the Public Securities to be sold in the Offering (including the Option Securities) with the Commission; (b) all Public Offering Filing System filing fees and expenses associated with the review of the Offering by FINRA; (c) all fees and expenses relating to the listing of such Public Securities on the Exchange and such other stock exchanges as the Company and the Representative together determine, including any fees charged by the DTC for new securities; (d) all fees, expenses and disbursements relating to background checks of the Company’s officers, directors and entities in an amount not to exceed $15,000 in the aggregate; (e) all fees, expenses and disbursements relating to the registration or qualification of such Public Securities under the “blue sky” securities laws of such states and other jurisdictions as the Representative may reasonably designate (including, without limitation, all filing and registration fees, it being agreed that if the Offering is commenced on the Exchange, the Company shall make a payment of $5,000 to such counsel at Closing, or if the Offering is commenced on the Over-the-Counter Bulletin Board, the Company shall make a payment of $15,000 to such counsel upon the commencement of “blue sky” work by such counsel and an additional $5,000 at Closing); (f) all fees, expenses and disbursements relating to the registration, qualification or exemption of such Public Securities under the securities laws of such foreign jurisdictions as the Representative may reasonably designate; (g) the costs of all mailing and printing of the underwriting documents (including, without limitation, the Underwriting Agreement, any Blue Sky Surveys and, if appropriate, any Agreement Among Underwriters, Selected Dealers’ Agreement, Underwriters’ Questionnaire and Power of Attorney), Registration Statements, Prospectuses and all amendments, supplements and exhibits thereto and as many preliminary and final Prospectuses as the Representative may reasonably deem necessary; (h) the costs and expenses of a public relations firm; (i) the costs of preparing, printing and delivering certificates representing the Public Securities; (j) fees and expenses of the transfer agent for the Common Shares; (k) fees and expenses of the warrant agent for the Warrants; (l) stock transfer, warrant transfer and/or stamp taxes, if any, payable upon the transfer of securities from the Company to the Underwriters; (m) the costs associated with bound volumes of the public offering materials as well as commemorative mementos and lucite tombstones, each of which the Company or its designee shall provide within a reasonable time after the Closing Date in such quantities as the Representative may reasonably request, in an amount not to exceed $3,000; (n) the fees and expenses of the Company’s accountants; (o) the fees and expenses of the Company’s legal counsel and other agents and representatives; (p) the fees and expenses of the Representative’s legal counsel not to exceed $125,000; (q) the $29,500 cost associated with the Underwriter’s use of Ipreo’s book-building, prospectus tracking and compliance software for the Offering; and (r) up to $15,000 of the Underwriters’ actual accountable “road show” expenses for the Offering. The Representative may deduct from the net proceeds of the Offering payable to the Company on the Closing Date, or the Option Closing Date, if any, the expenses set forth herein to be paid by the Company to the Underwriters.

 

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3.11.2 Non-accountable Expenses. The Company further agrees that, in addition to the expenses payable pursuant to Section 3.11.1, on the Closing Date it shall pay to the Representative, by deduction from the net proceeds of the Offering contemplated herein, a non-accountable expense allowance equal to one percent (1%) of the gross proceeds received by the Company from the sale of the Firm Units (excluding the Option Securities), provided, however, that in the event that the Offering is terminated, the Company agrees to reimburse the Underwriters pursuant to Section 8.3 hereof.

 

3.12 Application of Net Proceeds. The Company shall apply the net proceeds from the Offering received by it in a manner consistent with the application thereof described under the caption “Use of Proceeds” in the Registration Statement, the Pricing Disclosure Package and the Prospectus.

 

3.13 Rule 158. The Company shall timely file such reports pursuant to the Exchange Act as are necessary in order to make generally available to its security holders as soon as practicable an earnings statement for the purposes of, and to provide to the Underwriters the benefits contemplated by, Rule 158(a) under Section 11(a) of the Securities Act.

 

3.14 Stabilization. Neither the Company nor, to its knowledge, any of its employees, directors or shareholders (without the consent of the Representative) has taken or shall take, directly or indirectly, any action designed to or that has constituted or that might reasonably be expected to cause or result in, under Regulation M of the Exchange Act, or otherwise, stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Public Securities.

 

3.15 Internal Controls. The Company shall maintain a system of internal accounting controls sufficient to provide reasonable assurances that: (i) transactions are executed in accordance with management’s general or specific authorization; (ii) transactions are recorded as necessary in order to permit preparation of financial statements in accordance with IFRS and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences.

 

3.16 Accountants. The Company shall retain an independent registered public accounting firm reasonably acceptable to the Representative, and the Company shall continue to retain a nationally recognized independent registered public accounting firm for a period of at least three (3) years after the date of this Agreement. The Representative acknowledges that the Auditor is acceptable to the Representative.

 

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3.17 FINRA. The Company shall advise the Representative (who shall make an appropriate filing with FINRA) if it is or becomes aware that (i) any officer or director of the Company, (ii) any beneficial owner of 5% or more of any class of the Company’s securities or (iii) any beneficial owner of the Company’s unregistered equity securities which were acquired during the 180 days immediately preceding the original filing of the Registration Statement is or becomes an affiliate or associated person of a FINRA member participating in the Offering (as determined in accordance with the rules and regulations of FINRA).

 

3.18 Securities Laws Disclosure; Pre-Closing Publicity. At the request of the Representative, by 9:00 a.m. (New York City time) on the date following the date hereof, the Company shall issue a press release disclosing the material terms of the Offering. Except as set forth in the immediately preceding sentence, prior to the Closing Date and any Option Closing Date, the Company shall not issue any press release or other communication directly or indirectly or hold any press conference with respect to the Company, its condition, financial or otherwise, or earnings, business affairs or business prospects (except for routine oral marketing communications in the ordinary course of business and consistent with the past practices of the Company and of which the Representative is notified), without the prior written consent of the Representative, which consent shall not be unreasonably withheld, conditioned or delayed unless in the judgment of the Company and its counsel, and after notification to the Representative, such press release or communication is required by law.

 

3.19 No Fiduciary Duties. The Company acknowledges and agrees that the Underwriters’ responsibility to the Company is solely contractual in nature and that none of the Underwriters or their affiliates or any selling agent shall be deemed to be acting in a fiduciary capacity, or otherwise owes any fiduciary duty to the Company or any of its affiliates in connection with the Offering and the other transactions contemplated by this Agreement. Notwithstanding anything in this Agreement to the contrary, the Company acknowledges that the Underwriters may have financial interests in the success of the Offering that are not limited to the difference between the price to the public and the purchase price paid to the Company by the Underwriters for the Securities and the Underwriters have no obligation to disclose, or account to the Company for, any of such additional financial interests. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against the Underwriters with respect to any breach or alleged breach of fiduciary duty.

 

3.20 Company Lock-Up Agreements.

 

3.20.1 Restriction on Sales of Securities. The Company, on behalf of itself and any successor entity, agrees that, without the prior written consent of the Representative, it will not, for a period of three (3) months after the date of this Agreement (the “Lock-Up Period”): (i) offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, lend, or otherwise transfer or dispose of, directly or indirectly, any Common Shares, Pre-Funded Warrants, Warrants or any securities convertible into or exercisable or exchangeable for Common Shares; (ii) file or cause to be filed any registration statement with the Commission relating to the offering of any Common Shares, Pre-Funded Warrants, Warrants or any securities convertible into or exercisable or exchangeable for Common Shares (other than registration statements covering any employee or director stock option plan, incentive plan or stock ownership plan of the Company and only if any such plan is disclosed in the Registration Statement prior to the Effective Date and as long as the securities being registered are subject to lock-ups until at least six (6) months from the date of this Agreement); (iii) complete any offering of debt securities of the Company, other than entering into a line of credit with a traditional bank or (iv) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of Common Shares, Pre-Funded Warrants or Warrants, whether any such transaction described in clause (i), (ii), (iii) or (iv) above is to be settled by delivery of Common Shares, Pre-Funded Warrants, Warrants or such other securities, in cash or otherwise.

 

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The restrictions contained in this Section 3.20.1 shall not apply to (i) the Public Securities and the Representative’s Securities to be sold hereunder, (ii) the issuance by the Company of Common Shares upon the exercise of a stock option or warrant or the conversion of a security outstanding on the date hereof and disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, which terms may not be amended during the Lock-Up Period, provided that such options, warrants and securities have not been amended since the date of this Agreement to increase the number of such securities or to decrease the exercise price, exchange price or the conversion price of such securities or to extend the term of such securities, (iii) the grant by the Company of stock options or other stock-based awards, or the issuance of Common Shares under any equity compensation plan of the Company, or (iv) the issuance by the Company of Common Shares or other securities of the Company in connection with strategic transactions not for capital raising purposes, provided that in each of (ii) and (iii) above, the underlying Common Shares shall be restricted from sale during the entire Lock-Up Period.

 

3.20.2 Restriction on Continuous Offerings. Notwithstanding the restrictions contained in Section 3.20.1, the Company, on behalf of itself and any successor entity, agrees that, without the prior written consent of the Representative, it will not, for a period of 12 months after the date of this Agreement, directly or indirectly in any “at-the-market” or continuous equity transaction, offer to sell, sell, contract to sell, grant any option to sell or otherwise dispose of Common Shares or any securities convertible into or exercisable or exchangeable for Common Shares.

 

3.21 Release of D&O Lock-up Period. If the Representative, in its sole discretion, agrees to release or waive the restrictions set forth in the Lock-Up Agreements described in Section 2.23 hereof for an officer or director of the Company and provide the Company with notice of the impending release or waiver at least three (3) Business Days before the effective date of the release or waiver, the Company agrees to announce the impending release or waiver by a press release substantially in the form of Exhibit hereto through a major news service at least two (2) Business Days before the effective date of the release or waiver.

 

3.22 Blue Sky Qualifications. The Company shall use its best efforts, in cooperation with the Underwriters, if necessary, to qualify the Public Securities for offering and sale under the applicable securities laws of such states and other jurisdictions (domestic or foreign) as the Representative may designate and to maintain such qualifications in effect so long as required to complete the distribution of the Public Securities; provided, however, that the Company shall not be obligated to file any general consent to service of process or to qualify as a foreign corporation or as a dealer in securities in any jurisdiction in which it is not so qualified or to subject itself to taxation in respect of doing business in any jurisdiction in which it is not otherwise so subject.

 

3.23 Reporting Requirements. The Company, during the period when a prospectus relating to the Public Securities is (or, but for the exception afforded by Rule 172, would be) required to be delivered under the Securities Act, will file all documents required to be filed with the Commission pursuant to the Exchange Act within the time periods required by the Exchange Act and Exchange Act Regulations. Additionally, the Company shall report the use of proceeds from the issuance of the Public Securities as may be required under Rule 463 under the Securities Act Regulations.

 

3.24 Emerging Growth Company Status. The Company shall promptly notify the Representative if the Company ceases to be an Emerging Growth Company at any time prior to the later of (i) completion of the distribution of the Public Securities within the meaning of the Securities Act and (ii) fifteen (15) days following the completion of the Lock-Up Period.

 

3.25 IRS Forms. The Company shall deliver to each Underwriter (or its agent), prior to or at the Closing Date, a properly completed and executed Internal Revenue Service (“IRS”) Form W-9 or an IRS Form W-8, as appropriate, together with all required attachments to such form.

 

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4. Conditions of Underwriters’ Obligations. The obligations of the Underwriters to purchase and pay for the Firm Units and Option Securities, as provided herein, shall be subject to (i) the continuing accuracy of the representations and warranties of the Company as of the date hereof and as of each of the Closing Date and each Option Closing Date, if any; (ii) the accuracy of the statements of officers of the Company made pursuant to the provisions hereof; (iii) the performance by the Company of its obligations hereunder; and (iv) the following conditions:

 

4.1 Regulatory Matters.

 

4.1.1 Effectiveness of Registration Statement; Rule 430A Information. The Registration Statement has become effective not later than 5:00 p.m., Eastern time, on the date of this Agreement or such later date and time as shall be consented to in writing by the Representative, and, on each of the Closing Date and any Option Closing Date, no stop order suspending the effectiveness of the Registration Statement or any post-effective amendment thereto shall have been issued under the Securities Act, no order preventing or suspending the use of any Preliminary Prospectus or the Prospectus shall have been issued and no proceedings for any of those purposes have been instituted or are pending or, to the Company’s knowledge, contemplated by the Commission. The Company has complied with each request (if any) from the Commission for additional information. The Prospectus containing the Rule 430A Information shall have been filed with the Commission in the manner and within the time frame required by Rule 424(b) (without reliance on Rule 424(b)(8)) or a post-effective amendment providing such information shall have been filed with, and declared effective by, the Commission in accordance with the requirements of Rule 430A.

 

4.1.2 No Cease Trade Order. On each of the Closing Date and any Option Closing Date, no Cease Trade Order shall have been issued by any Canadian Securities Regulator and no proceedings for such purpose, to the knowledge of the Company, will be pending or threatened.

 

4.1.3 FINRA Clearance. On or before the date of this Agreement, the Representative shall have received correspondence from FINRA that it will raise no objection as to the amount of compensation allowable or payable to the Underwriters as described in the Registration Statement.

 

4.1.4 Exchange Stock Market Clearance. On the Closing Date, the Firm Units shall have been approved for listing on the Exchange, subject only to official notice of issuance. On each Option Closing Date (if any), the Option Securities shall have been approved for listing on the Exchange, subject only to official notice of issuance, if needed.

 

4.1.5 TSXV Acceptance. On the Closing Date, the TSXV shall have conditionally accepted the Offering and the listing of the Firm Shares, the Option Shares and the Underlying Common Shares, subject only to the satisfaction of the customary listing conditions.

 

4.2 Company Counsel Matters.

 

4.2.1 Closing Date Opinion of U.S. Counsel. On the Closing Date, the Representative shall have received the favorable opinion of Sichenzia Ross Ference LLP, U.S. legal counsel to the Company, dated the Closing Date and addressed to the Representative, substantially in the form of Exhibit E attached hereto.

 

4.2.2 Closing Date Opinion of Canadian Counsel. On the Closing Date, the Representative shall have received the favorable opinion of Bennett Jones LLP, Canadian legal counsel to the Company, dated the Closing Date and addressed to the Representative, substantially in the form of Exhibit F attached hereto and containing customary assumptions and exclusions.

 

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4.2.3 Opinions of Special Intellectual Property Counsel and Special Intellectual Property Counsel (Licensing) for the Company. On the Closing Date, the Representative shall have received the opinions of Kilpatrick Townsend & Stockton LLP, special intellectual property counsel for the Company, and Remenick PLLC, special intellectual property counsel (licensing) for the Company, dated the Closing Date, addressed to the Representative substantially in the form of Exhibit G and Exhibit F, respectively, attached hereto.

 

4.2.4 Option Closing Date Opinions of Counsel. On the Option Closing Date, if any, the Representative shall have received the favorable opinions of each counsel listed in Sections 4.2.1, 4.2.2 and 4.2.3, dated the Option Closing Date, addressed to the Representative and in form and substance reasonably satisfactory to the Representative, confirming as of the Option Closing Date, the statements made by such counsels in their respective opinions delivered on the Closing Date.

 

4.2.5 Reliance. In rendering such opinions, such counsel may rely: (i) as to matters involving the application of laws other than the laws of the United States and Canada and jurisdictions in which they are admitted, to the extent such counsel deems proper and to the extent specified in such opinion, if at all, upon an opinion or opinions (in form and substance reasonably satisfactory to the Representative) of other counsel reasonably acceptable to the Representative, familiar with the applicable laws, and alternatively, such opinion of other counsel may be addressed directly to the Representative and the other Underwriters; and (ii) as to matters of fact, to the extent they deem proper, on certificates or other written statements of officers of the Company and officers of departments of various jurisdictions having custody of documents respecting the corporate existence or good standing of the Company, provided that copies of any such statements or certificates shall be delivered to Representative Counsel if requested. The opinions of each counsel listed in Sections 4.2.1, 4.2.2 and 4.2.3, and any opinions relied upon by such counsel shall include a statement to the effect that they may be relied upon by Representative Counsel in such counsel’s opinions delivered to the Underwriters.

 

4.3 Comfort Letters.

 

4.3.1 Cold Comfort Letter. At the time this Agreement is executed, the Representative shall have received a cold comfort letter from the Auditor containing statements and information of the type customarily included in accountants’ comfort letters with respect to the financial statements and certain financial information contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus, addressed to the Representative and in form and substance satisfactory in all respects to the Representative and to the Auditor, dated as of the date of this Agreement.

 

4.3.2 Bring-down Comfort Letter. At each of the Closing Date and the Option Closing Date, if any, the Representative shall have received from the Auditor a letter, dated as of the Closing Date or the Option Closing Date, as applicable, to the effect that the Auditor reaffirms the statements made in the letter furnished pursuant to Section 4.3.1, except that the specified date referred to shall be a date not more than three (3) business days prior to the Closing Date or the Option Closing Date, as applicable.

 

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4.4 Officers’ Certificates.

 

4.4.1 Officers’ Certificate. The Company shall have furnished to the Representative a certificate, dated the Closing Date or Option Closing Date, as applicable, of its President and Chief Executive Officer, and its Chief Financial Officer stating that (i) such officers have carefully examined the Registration Statement, the Pricing Disclosure Package, any Issuer Free Writing Prospectus and the Prospectus and, in their opinion, the Registration Statement and each amendment thereto, as of the Applicable Time and as of the Closing Date or Option Closing Date, as applicable, did not include any untrue statement of a material fact and did not omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading, and the Pricing Disclosure Package, as of the Applicable Time and as of the Closing Date or Option Closing Date, as applicable, any Issuer Free Writing Prospectus as of its date and as of the Closing Date or Option Closing Date, as applicable, the Prospectus and each amendment or supplement thereto, as of the respective date thereof and as of the Closing Date or Option Closing Date, as applicable, did not include any untrue statement of a material fact and did not omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances in which they were made, not misleading, (ii) since the effective date of the Registration Statement, no event has occurred which should have been set forth in a supplement or amendment to the Registration Statement, the Pricing Disclosure Package or the Prospectus, (iii) as of the Closing Date or Option Closing Date, as applicable, the representations and warranties of the Company in this Agreement are true and correct and the Company has complied with all agreements and satisfied all conditions on its part to be performed or satisfied hereunder at or prior to the Closing Date or Option Closing Date, as applicable, and (iv) there has not been, subsequent to the date of the most recent audited financial statements included in the Pricing Disclosure Package, any Material Adverse Change in the financial position or results of operations of the Company, or any change or development that, singularly or in the aggregate, would involve a Material Adverse Change, in or affecting the condition (financial or otherwise), results of operations, business, assets or prospects of the Company, except as set forth in the Prospectus.

 

4.4.2 Secretary’s Certificate. At each of the Closing Date and any Option Closing Date, the Representative shall have received a certificate of the Company signed by the Secretary of the Company, dated the Closing Date or Option Closing Date, as applicable, certifying: (i) that each of the Charter and similar governing documents is true and complete, has not been modified and is in full force and effect; (ii) that the resolutions of the Board relating to the Offering are in full force and effect and have not been modified; (iii) as to the accuracy and completeness of all correspondence between the Company or its counsel and the Commission; (iv) the good standing and the foreign qualification of the Company and its Subsidiaries; and (v) as to the incumbency of the officers of the Company. The documents referred to in such certificate shall be attached to such certificate.

 

4.5 No Material Changes. Prior to and on each of the Closing Date and each Option Closing Date, if any: (i) there shall have been no Material Adverse Change or development involving a prospective Material Adverse Change in the condition or prospects or the business activities, financial or otherwise, of the Company, or any of its Subsidiaries, from the latest dates as of which such condition is set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (ii) no action, suit or proceeding, at law or in equity, shall have been pending or threatened against the Company or any Insider before or by any court or federal or state commission, board or other administrative agency wherein an unfavorable decision, ruling or finding would reasonably be expected to result in a Material Adverse Change, except as set forth in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (iii) no stop order shall have been issued under the Securities Act and no proceedings therefor shall have been initiated or threatened by the Commission; (iv) no Cease Trade Order shall have been issued by any Canadian Securities Regulator; and (v) the Registration Statement, the Pricing Disclosure Package and the Prospectus and any amendments or supplements thereto shall contain all material statements which are required to be stated therein in accordance with the Securities Act and the Securities Act Regulations and shall conform in all material respects to the requirements of the Securities Act and the Securities Act Regulations, and neither the Registration Statement, the Pricing Disclosure Package nor the Prospectus nor any amendment or supplement thereto shall contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading.

 

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4.6 No Material Misstatement or Omission. The Underwriters shall not have discovered and disclosed to the Company on or prior to the Closing Date and any Option Closing Date that the Registration Statement or any amendment or supplement thereto contains an untrue statement of a fact which, in the opinion of Representative Counsel, is material or omits to state any fact which, in the opinion of such counsel, is material and is required to be stated therein or is necessary to make the statements therein not misleading, or that the Registration Statement, the Pricing Disclosure Package, any Issuer Free Writing Prospectus or the Prospectus or any amendment or supplement thereto contains an untrue statement of fact which, in the opinion of such counsel, is material or omits to state any fact which, in the opinion of such counsel, is material and is necessary in order to make the statements, in the light of the circumstances under which they were made, not misleading.

 

4.7 Corporate Proceedings. All corporate proceedings and other legal matters incident to the authorization, form and validity of each of this Agreement, the Pre-Funded Warrant Certificates, the Warrant Agreement, the Representative’s Warrant Agreement, the Public Securities, the Registration Statement, the Pricing Disclosure Package, each Issuer Free Writing Prospectus, if any, and the Prospectus and all other legal matters relating to this Agreement, the Pre-Funded Warrant Certificates, the Warrant Agreement, the Representative’s Warrant Agreement and the transactions contemplated hereby and thereby shall be reasonably satisfactory in all material respects to Representative Counsel, and the Company shall have furnished to such counsel all documents and information that they may reasonably request to enable them to pass upon such matters.

 

4.8 Delivery of Agreements.

 

4.8.1 Lock-Up Agreements. On or before the date of this Agreement, the Company shall have delivered to the Representative executed copies of the Lock-Up Agreements from each of the persons listed in Schedule 3 hereto.

 

4.8.2 Warrant Agreement. On or before the Closing Date, the Company shall have delivered to the Representative an executed copy of the Warrant Agreement.

 

4.8.3 Pre-Funded Warrant Certificates. On each of the Closing Date and any Option Closing Date, the Company shall have delivered to the Representative executed copies of the Pre-Funded Warrant Certificates.

 

4.8.4 Representative’s Warrant Agreement. On each of the Closing Date and any Option Closing Date, the Company shall have delivered to the Representative an executed copy of the Representative’s Warrant Agreement.

 

4.9 Additional Documents. On the Closing Date and on each Option Closing Date (if any) Representative Counsel shall have been furnished with such documents and opinions as they may require for the purpose of enabling Representative Counsel to deliver an opinion to the Underwriters, or in order to evidence the accuracy of any of the representations or warranties, or the fulfillment of any of the conditions, herein contained; and all proceedings taken by the Company in connection with the issuance and sale of the Firm Units, the Option Securities (as applicable) and the Representative’s Warrant as herein contemplated shall be satisfactory in form and substance to the Representative and Representative Counsel.

 

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5. Indemnification.

 

5.1 Indemnification of the Underwriters.

 

5.1.1 General. The Company agrees to indemnify and hold harmless each Underwriter, its affiliates and each of its and their respective directors, officers, members, employees, representatives, partners, shareholders, affiliates, counsel, and agents and each person, if any, who controls any such Underwriter within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act (collectively the “Underwriter Indemnified Parties,” and each an “Underwriter Indemnified Party”), against any and all loss, liability, claim, judgment, assessment, damage and expense whatsoever (including but not limited to any and all legal or other expenses reasonably incurred in investigating, preparing or defending against any litigation, commenced or threatened, or any claim whatsoever, whether arising out of any action between any of the Underwriter Indemnified Parties and the Company or between any of the Underwriter Indemnified Parties and any third party, or otherwise) to which they or any of them may become subject under the Securities Act, the Exchange Act or any other statute or at common law or otherwise or under the laws of foreign countries (a “Claim”), (i) arising out of or based upon any untrue statement or alleged untrue statement of a material fact contained in (A) the Registration Statement, the Pricing Disclosure Package, any Preliminary Prospectus, the Prospectus, or in any Issuer Free Writing Prospectus or in any Written Testing-the-Waters Communication (as from time to time each may be amended and supplemented); (B) any materials or information provided to investors by, or with the approval of, the Company in connection with the marketing of the Offering, including any “road show” or investor presentations made to investors by the Company (whether in person or electronically); or (C) any application or other document or written communication (in this Section 5, collectively called “application”) executed by the Company or based upon written information furnished by the Company in any jurisdiction in order to qualify the Public Securities and Representative’s Securities under the securities laws thereof or filed with the Commission, any state securities commission or agency, the Exchange, any other national securities exchange or the TSXV; or the omission or alleged omission therefrom of a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading, unless such statement or omission was made in reliance upon, and in conformity with, the Underwriters’ Information or (ii) otherwise arising in connection with or allegedly in connection with the Offering. The Company also agrees that it will reimburse each Underwriter Indemnified Party for all fees and expenses (including but not limited to any and all legal or other expenses reasonably incurred in investigating, preparing or defending against any litigation, commenced or threatened, or any claim whatsoever, whether arising out of any action between any of the Underwriter Indemnified Parties and the Company or between any of the Underwriter Indemnified Parties and any third party, or otherwise) (collectively, the “Expenses”), and further agrees wherever and whenever possible to advance payment of Expenses as they are incurred by an Underwriter Indemnified Party in investigating, preparing, pursuing or defending any Claim.

 

5.1.2 Procedure. Upon receipt by an Underwriter Indemnified Party of actual notice of an action against an Underwriter Indemnified Party in respect of which indemnity may be sought against the Company pursuant to Section 5.1.1, such Underwriter Indemnified Party shall promptly notify the Company in writing of the institution of such action, provided that failure by any Underwriter Indemnified Party shall not relieve the Company of any obligation or liability which the Company may have on account of this Section 5 or otherwise to such Underwriter Indemnified Party, and the Company shall assume the defense of such action, including the employment and reasonable fees of counsel (subject to the approval of such Underwriter Indemnified Party) and payment of actual expenses if an Underwriter Indemnified Party requests that the Company do so. Such Underwriter Indemnified Party shall also have the right to employ its or their own counsel in any such case, but the fees and expenses of such counsel shall be at the expense of the Company, and shall be advanced by the Company. The Company shall not be liable for any settlement of any action effected without its consent (which shall not be unreasonably withheld). In addition, the Company shall not, without the prior written consent of the Underwriters, settle, compromise or consent to the entry of any judgment in or otherwise seek to terminate any pending or threatened action in respect of which advancement, reimbursement, indemnification or contribution may be sought hereunder (whether or not such Underwriter Indemnified Party is a party thereto) unless such settlement, compromise, consent or termination (i) includes an unconditional release of each Underwriter Indemnified Party, acceptable to such Underwriter Indemnified Party, from all liabilities, expenses and claims arising out of such action for which indemnification or contribution may be sought and (ii) does not include a statement as to or an admission of fault, culpability or a failure to act, by or on behalf of any Underwriter Indemnified Party.

 

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5.2 Indemnification of the Company. Each Underwriter, severally and not jointly, agrees to indemnify and hold harmless the Company, its directors, its officers who signed the Registration Statement and persons who control the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act against any and all loss, liability, claim, judgment, assessment, damage and expense described in the foregoing indemnity from the Company to the several Underwriters, as incurred, but only with respect to untrue statements or omissions, or alleged untrue statements or omissions made in the Registration Statement, any Preliminary Prospectus, the Pricing Disclosure Package or Prospectus or any amendment or supplement thereto or in any application, in reliance upon, and in strict conformity with, the Underwriters’ Information. In case any action shall be brought against the Company or any other person so indemnified based on any Preliminary Prospectus, the Registration Statement, the Pricing Disclosure Package or Prospectus or any amendment or supplement thereto or any application, and in respect of which indemnity may be sought against any Underwriter, such Underwriter shall have the rights and duties given to the Company, and the Company and each other person so indemnified shall have the rights and duties given to the several Underwriters by the provisions of Section 5.1.2. The Company agrees promptly to notify the Representative of the commencement of any litigation or proceedings against the Company or any of its officers, directors or any person, if any, who controls the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act, in connection with the issuance and sale of the Public Securities or in connection with the Registration Statement, the Pricing Disclosure Package, the Prospectus, or any Issuer Free Writing Prospectus or any Written Testing-the-Waters Communication.

 

5.3 Contribution.

 

5.3.1 Contribution Rights. If the indemnification provided for in this Section 5 shall for any reason be unavailable to or insufficient to hold harmless an indemnified party under Section 5.1 or 5.2 in respect of any loss, liability, claim, judgment, assessment, damage or expense, or any action in respect thereof, referred to therein, then each indemnifying party shall, in lieu of indemnifying such indemnified party, contribute to the amount paid or payable by such indemnified party as a result of such loss, liability, claim, judgment, assessment, damage or expense, or action in respect thereof, (i) in such proportion as shall be appropriate to reflect the relative benefits received by the Company, on the one hand, and the Underwriters, on the other, from the Offering, or (ii) if the allocation provided by clause (i) above is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative benefits referred to in clause (i) above but also the relative fault of the Company, on the one hand, and the Underwriters, on the other, with respect to the statements or omissions that resulted in such loss, claim, damage or liability, or action in respect thereof, as well as any other relevant equitable considerations. The relative benefits received by the Company, on the one hand, and the Underwriters, on the other, with respect to such Offering shall be deemed to be in the same proportion as the total net proceeds from the Offering of the Public Securities purchased under this Agreement (before deducting expenses) received by the Company, as set forth in the table on the cover page of the Prospectus, on the one hand, and the total underwriting discounts and commissions received by the Underwriters with respect to the Public Securities purchased under this Agreement, as set forth in the table on the cover page of the Prospectus, on the other hand. The relative fault shall be determined by reference to whether the untrue or alleged untrue statement of a material fact or omission or alleged omission to state a material fact relates to information supplied by the Company or the Underwriters, the intent of the parties and their relative knowledge, access to information and opportunity to correct or prevent such statement or omission. The Company and the Underwriters agree that it would not be just and equitable if contributions pursuant to this Section 5.3.1 were to be determined by pro rata allocation (even if the Underwriters were treated as one entity for such purpose) or by any other method of allocation that does not take into account the equitable considerations referred to herein. The amount paid or payable by an indemnified party as a result of the loss, liability, claim, judgment, assessment, damage or expense, or action in respect thereof, referred to above in this Section 5.3.1 shall be deemed to include, for purposes of this Section 5.3.1, any legal or other expenses reasonably incurred by such indemnified party in connection with investigating or defending any such action or claim. Notwithstanding the provisions of this Section 5.3.1 in no event shall an Underwriter be required to contribute any amount in excess of the amount by which the total underwriting discounts and commissions received by such Underwriter with respect to the Offering of the Public Securities exceeds the amount of any damages that such Underwriter has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation.

 

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5.3.2 Contribution Procedure. Within fifteen (15) days after receipt by any party to this Agreement (or its representative) of notice of the commencement of any action, suit or proceeding, such party will, if a claim for contribution in respect thereof is to be made against another party (“contributing party”), notify the contributing party of the commencement thereof, but the failure to so notify the contributing party will not relieve it from any liability which it may have to any other party other than for contribution hereunder. In case any such action, suit or proceeding is brought against any party, and such party notifies a contributing party or its representative of the commencement thereof within the aforesaid 15 days, the contributing party will be entitled to participate therein with the notifying party and any other contributing party similarly notified. Any such contributing party shall not be liable to any party seeking contribution on account of any settlement of any claim, action or proceeding affected by such party seeking contribution on account of any settlement of any claim, action or proceeding affected by such party seeking contribution without the written consent of such contributing party. The contribution provisions contained in this Section 5.3.2 are intended to supersede, to the extent permitted by law, any right to contribution under the Securities Act, the Exchange Act or otherwise available. Each Underwriter’s obligations to contribute pursuant to this Section 5.3 are several and not joint.

 

6. Default by an Underwriter.

 

6.1 Default Not Exceeding 10% of Firm Units or Option Securities. If any Underwriter or Underwriters shall default in its or their obligations to purchase the Firm Units or the Option Securities, if the Over-allotment Option is exercised hereunder, and if the number of the Firm Units or Option Securities with respect to which such default relates does not exceed in the aggregate 10% of the number of Firm Units or Option Securities that all Underwriters have agreed to purchase hereunder, then such Firm Units or Option Securities to which the default relates shall be purchased by the non-defaulting Underwriters in proportion to their respective commitments hereunder.

 

6.2 Default Exceeding 10% of Firm Units or Option Securities. In the event that the default addressed in Section 6.1 relates to more than 10% of the Firm Units or Option Securities, the Representative may in its discretion arrange for itself or for another party or parties to purchase such Firm Units or Option Securities to which such default relates on the terms contained herein. If, within one (1) Business Day after such default relating to more than 10% of the Firm Units or Option Securities, the Representative does not arrange for the purchase of such Firm Units or Option Securities, then the Company shall be entitled to a further period of one (1) Business Day within which to procure another party or parties satisfactory to the Representative to purchase said Firm Units or Option Securities on such terms as the Representative agrees. In the event that neither the Representative nor the Company arrange for the purchase of the Firm Units or Option Securities to which a default relates as provided in this Section 6, this Agreement will automatically be terminated by the Representative or the Company without liability on the part of the Company (except as provided in Sections 3.11 and 5 hereof) or the several Underwriters (except as provided in Section 5 hereof); provided, however, that if such default occurs with respect to the Option Securities, this Agreement will not terminate as to the Firm Units; and provided, further, that nothing herein shall relieve a defaulting Underwriter of its liability, if any, to the other Underwriters and to the Company for damages occasioned by its default hereunder.

 

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6.3 Postponement of Closing Date. In the event that the Firm Units or Option Securities to which the default relates are to be purchased by the non-defaulting Underwriters, or are to be purchased by another party or parties as aforesaid, the Representative or the Company shall have the right to postpone the Closing Date or Option Closing Date for a reasonable period, but not in any event exceeding five (5) Business Days, in order to effect whatever changes may thereby be made necessary in the Registration Statement, the Pricing Disclosure Package or the Prospectus or in any other documents and arrangements, and the Company agrees to file promptly any amendment to the Registration Statement, the Pricing Disclosure Package or the Prospectus that in the opinion of Representative Counsel may thereby be made necessary. The term “Underwriter” as used in this Agreement shall include any party substituted under this Section 6 with like effect as if it had originally been a party to this Agreement with respect to such Securities.

 

7. Additional Covenants.

 

7.1 Board Composition and Board Designations. The Company shall ensure that: (i) the qualifications of the persons serving as members of the Board and the overall composition of the Board comply with the Sarbanes-Oxley Act, with the Exchange Act and with the listing rules of the Exchange or any other national securities exchange, as the case may be, in the event the Company seeks to have its Public Securities listed on another exchange or quoted on an automated quotation system, and (ii) if applicable, at least one member of the Audit Committee of the Board qualifies as an “audit committee financial expert,” as such term is defined under Regulation S-K and the listing rules of the Exchange.

 

7.2 Prohibition on Press Releases and Public Announcements. The Company shall not issue press releases or engage in any other publicity, without the Representative’s prior written consent, such consent not to be unreasonably withhold, conditioned or delayed, for a period ending at 5:00 p.m., Eastern time, on the first (1st) Business Day following the fortieth (40th) day after the Closing Date, other than normal and customary releases issued in the ordinary course of the Company’s business.

 

7.3 Right of First Refusal. Provided that the Firm Units are sold in accordance with the terms of this Agreement, the Representative shall have an irrevocable right of first refusal (the “Right of First Refusal”), for a period of eighteen (18) months after the date the Offering is completed, (i) to act as sole and exclusive investment banker, sole and exclusive book-runner, sole and exclusive underwriter and/or sole and exclusive placement agent for each and every future public and private equity and debt offering, including all equity linked financings of the Company, or any successor to or subsidiary of the Company (each, a “Financing Transaction”) and (ii) to act as sole and exclusive financial advisor of the Company or any successor to or subsidiary of the Company in connection with (A) the acquisition or disposition of business units or assets, (B) the acquisition of any of its outstanding securities, (C) an exchange or tender offer, or (D) a merger, amalgamation, arrangement, consolidation or other business combination or any recapitalization, reorganization, restructuring or other similar transaction, including, without limitation, an extraordinary dividend or distributions or a spin-off or split-off (each, an “Acquisition Transaction” and together with a Financing Transaction, each, a “Subject Transaction”), at the Representative’s sole and exclusive discretion, during such eighteen (18) month period, on terms and conditions customary to the Representative for such Subject Transactions. The Representative will have the sole right to determine whether or not any other broker dealer will have the right to participate in any Subject Transaction and the economic terms of any such participation. For the avoidance of any doubt, the Company shall not retain, engage or solicit any additional investment banker, book-runner, financial advisor, underwriter and/or placement agent in a Subject Transaction without the express written consent of the Representative.

 

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The Company shall notify the Representative of its intention to pursue a Subject Transaction, including the material terms thereof, by providing written notice thereof by registered mail or overnight courier service addressed to the Representative. If the Representative fails to exercise its Right of First Refusal with respect to any Subject Transaction within ten (10) Business Days after the mailing of such written notice, then the Representative shall have no further claim or right with respect to the Subject Transaction. The Representative may elect, in its sole and absolute discretion, not to exercise its Right of First Refusal with respect to any Subject Transaction; provided that any such election by the Representative shall not adversely affect the Representative’s Right of First Refusal with respect to any other Subject Transaction during the eighteen (18) month period agreed to above.

 

8. Effective Date of this Agreement and Termination Thereof.

 

8.1 Effective Date. This Agreement shall become effective when both the Company and the Representative have executed the same and delivered counterparts of such signatures to the other party.

 

8.2 Termination. The Representative shall have the right to terminate this Agreement at any time prior to any Closing Date, (i) if any domestic or international event or act or occurrence has materially disrupted, or in the Representative’s opinion will in the immediate future materially disrupt, general securities markets in the United States; or (ii) if trading on the New York Stock Exchange or the Nasdaq Stock Market LLC shall have been suspended or materially limited, or minimum or maximum prices for trading shall have been fixed, or maximum ranges for prices for securities shall have been required by FINRA or by order of the Commission or any other government authority having jurisdiction; or (iii) if the United States shall have become involved in a new war or an increase in major hostilities; or (iv) if a banking moratorium has been declared by a New York State or federal authority; or (v) if a moratorium on foreign exchange trading has been declared which materially adversely impacts the United States securities markets; or (vi) if the Company shall have sustained a material loss by fire, flood, accident, hurricane, earthquake, theft, sabotage or other calamity or malicious act which, whether or not such loss shall have been insured, will, in the Representative’s opinion, make it inadvisable to proceed with the delivery of the Firm Units or Option Securities; or (vii) if the Company is in material breach of any of its representations, warranties or covenants hereunder; or (viii) if the Representative shall have become aware after the date hereof of such a Material Adverse Change in the conditions or prospects of the Company, or such adverse material change in general market conditions as in the Representative’s judgment would make it impracticable to proceed with the offering, sale and/or delivery of the Public Securities or to enforce contracts made by the Underwriters for the sale of the Public Securities.

 

8.3 Expenses. Notwithstanding anything to the contrary in this Agreement, except in the case of a default by the Underwriters, pursuant to Section 6.2 above, in the event that this Agreement shall not be carried out for any reason whatsoever, within the time specified herein or any extensions thereof pursuant to the terms herein, the Company shall be obligated to pay to the Underwriters their actual and accountable out-of-pocket expenses related to the transactions contemplated herein then due and payable (including the fees and disbursements of Representative Counsel) up to $150,000, inclusive of the $30,000 advance for accountable expenses previously paid by the Company to the Representative (the “Advance”) and upon demand the Company shall pay the full amount thereof to the Representative on behalf of the Underwriters; provided, however, that such expense cap in no way limits or impairs the indemnification and contribution provisions of this Agreement. Notwithstanding the foregoing, any advance received by the Representative will be reimbursed to the Company to the extent not actually incurred in compliance with FINRA Rule 5110(f)(2)(C).

 

8.4 Indemnification. Notwithstanding any contrary provision contained in this Agreement, any election hereunder or any termination of this Agreement, and whether or not this Agreement is otherwise carried out, the provisions of Section 5 shall remain in full force and effect and shall not be in any way affected by, such election or termination or failure to carry out the terms of this Agreement or any part hereof.

 

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8.5 Representations, Warranties, Agreements to Survive. All representations, warranties and agreements contained in this Agreement or in certificates of officers of the Company submitted pursuant hereto, shall remain operative and in full force and effect regardless of (i) any investigation made by or on behalf of any Underwriter or its Affiliates or selling agents, any person controlling any Underwriter, its officers or directors or any person controlling the Company or (ii) delivery of and payment for the Public Securities.

 

9. Miscellaneous.

 

9.1 Notices. All communications hereunder, except as herein otherwise specifically provided, shall be in writing and shall be mailed (registered or certified mail, return receipt requested), personally delivered or sent by facsimile transmission and confirmed and shall be deemed given when so delivered or faxed and confirmed or if mailed, two (2) days after such mailing.

 

If to the Representative:

 

ThinkEquity

17 State Street, 22nd Fl

New York, NY 10004

 

Attn: Mr. Eric Lord, Head of Investment Banking

 

Fax No.: (212) 349-2550

 

with a copy (which shall not constitute notice) to:

 

Clark Wilson LLP

900 – 885 West Georgia Street

Vancouver, BC V6C 3H1

Canada

 

Attn: Mr. Virgil Z. Hlus

 

Fax No.: (604)687-6314

 

If to the Company:

 

BriaCell Therapeutics Corp.

Suite 300, Bellevue Centre

235 – 15th Street

West Vancouver, BC V7T 2X1

Canada

 

Attention: Dr. William V. Williams

 

Fax No: (424) 245-3719

 

with a copy (which shall not constitute notice) to:

 

Sichenzia Ross Ference LLP

1185 Avenue of the Americas, 37th Floor

New York, NY 10036

 

Attention: Mr. Gregory Sichenzia

 

Fax No: (212) 930-9725

 

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9.2 Headings. The headings contained herein are for the sole purpose of convenience of reference, and shall not in any way limit or affect the meaning or interpretation of any of the terms or provisions of this Agreement.

 

9.3 Amendment. This Agreement may only be amended by a written instrument executed by each of the parties hereto.

 

9.4 Entire Agreement. This Agreement (together with the other agreements and documents being delivered pursuant to or in connection with this Agreement) constitutes the entire agreement of the parties hereto with respect to the subject matter hereof and thereof, and supersedes all prior agreements and understandings of the parties, oral and written, with respect to the subject matter hereof. Notwithstanding anything to the contrary set forth herein, it is understood and agreed by the parties hereto that all other terms and conditions of that certain engagement letter between the Company and the Representative dated August 13, 2019, shall remain in full force and effect.

 

9.5 Binding Effect. This Agreement shall inure solely to the benefit of and shall be binding upon the Representative, the Underwriters, each Underwriter Indemnified Party referred to in Section 5, the Company and the controlling persons, directors and officers referred to in Section 5 hereof, and their respective successors, legal representatives, heirs and assigns, and no other person shall have or be construed to have any legal or equitable right, remedy or claim under or in respect of or by virtue of this Agreement or any provisions herein contained. The term “successors and assigns” shall not include a purchaser, in its capacity as such, of securities from any of the Underwriters.

 

9.6 Governing Law; Consent to Jurisdiction; Trial by Jury. This Agreement shall be governed by and construed and enforced in accordance with the laws of the State of New York, without giving effect to conflict of laws principles thereof. The Company hereby agrees that any action, proceeding or claim against it arising out of, or relating in any way to this Agreement shall be brought and enforced in the New York Supreme Court, County of New York, or in the United States District Court for the Southern District of New York, and irrevocably submits to such jurisdiction, which jurisdiction shall be exclusive. The Company hereby waives any objection to such exclusive jurisdiction and that such courts represent an inconvenient forum. Any such process or summons to be served upon the Company may be served by transmitting a copy thereof by registered or certified mail, return receipt requested, postage prepaid, addressed to it at the address set forth in Section 9.1 hereof. Such mailing shall be deemed personal service and shall be legal and binding upon the Company in any action, proceeding or claim. The Company agrees that the prevailing party(ies) in any such action shall be entitled to recover from the other party(ies) all of its reasonable attorneys’ fees and expenses relating to such action or proceeding and/or incurred in connection with the preparation therefor. The Company (on its behalf and, to the extent permitted by applicable law, on behalf of its shareholders and affiliates) and each of the Underwriters hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Agreement or the transactions contemplated hereby.

 

9.7 Execution in Counterparts. This Agreement may be executed in one or more counterparts, and by the different parties hereto in separate counterparts, each of which shall be deemed to be an original, but all of which taken together shall constitute one and the same agreement, and shall become effective when one or more counterparts has been signed by each of the parties hereto and delivered to each of the other parties hereto. Delivery of a signed counterpart of this Agreement by facsimile or email/pdf transmission shall constitute valid and sufficient delivery thereof.

 

9.8 Waiver, etc. The failure of any of the parties hereto to at any time enforce any of the provisions of this Agreement shall not be deemed or construed to be a waiver of any such provision, nor to in any way effect the validity of this Agreement or any provision hereof or the right of any of the parties hereto to thereafter enforce each and every provision of this Agreement. No waiver of any breach, non-compliance or non-fulfillment of any of the provisions of this Agreement shall be effective unless set forth in a written instrument executed by the party or parties against whom or which enforcement of such waiver is sought; and no waiver of any such breach, non-compliance or non-fulfillment shall be construed or deemed to be a waiver of any other or subsequent breach, non-compliance or non-fulfillment.

 

[Signature Page Follows]

 

 - 45 - 
 

 

If the foregoing correctly sets forth the understanding between the Underwriters and the Company, please so indicate in the space provided below for that purpose, whereupon this letter shall constitute a binding agreement between us.

 

Very truly yours,

 

BRIACELL THERAPEUTICS CORP.  
     
By:    
Name: William V. Williams  
Title: President and Chief Executive Officer  

 

Confirmed as of the date first written above mentioned, on behalf of itself and as Representative of the several Underwriters named on Schedule 1 hereto:

 

THINKEQUITY  
A Division of Fordham Financial Management, Inc.  
     
By:                        
Name:    
Title:    

 

[SIGNATURE PAGE]

 

BriaCell Therapeutics Corp. – Underwriting Agreement

 

   
 

 

Schedule 1

 

Underwriter   Total Number of
Firm Units
to be Purchased
  Number of Option
Securities to be Purchased
if the Over-Allotment
Option is Fully Exercised
ThinkEquity, a division of Fordham Financial Management, Inc.  

Class A:

Class B:

   
         
         
TOTAL:        

 

 Sch. 1-1  
 

 

Schedule 2-A

 

Pricing Information

 

 

Number of Firm Units:   t  
● Number of Class A Firm Units   t  
● Number of Class B Firm Units   t  
Number of Option Shares and/or Option Pre-Funded Warrants:   t  
Number of Option Warrants:   t  
Public Offering Price per Class A Firm Unit: $ t  
Public Offering Price per Class B Firm Unit: $ t  
Exercise Price per Pre-Funded Warrant: $ t  
Exercise Price per Warrant: $ t  
Price per Option Share: $ t  
Price per Option Pre-Funded Warrant: $ t

 
Price per Option Warrant: $ t  
Underwriting Discount per Class A Firm Unit: $ t  
Underwriting Discount per Class B Firm Unit: $ t  
Underwriting Discount per Option Share: $ t  
Underwriting Discount per Option Pre-Funded Warrant: $ t  
Underwriting Discount per Option Warrant: $ t  
Non-accountable expense allowance per Firm Unit: $ t  

 

Schedule 2-B

 

Issuer General Use Free Writing Prospectuses

 

[None.]

 

Schedule 2-C

 

Written Testing-the-Waters Communications

 

[None.]

 

 Sch. 2-1  
 

 

Schedule 3

 

List of Lock-Up Parties

 

Name   Title
William V. Williams   President, Chief Executive Officer and Director
Gadi Levin   Chief Financial Officer and Secretary
Jamieson Bondarenko   Chairman of the Board of Directors
Vaughn C. Embro-Patalony   Director
Rebecca Taub   Director
Charles Wiseman   Director
Richard Berman   Director

 

 Sch. 3-1  
 

 

Exhibit A

 

Form of Pre-Funded Warrant Certificate

 

PRE-FUNDED COMMON SHARE PURCHASE WARRANT

 

briacell therapeutics corp.

 

Warrant Shares: _______ Initial Exercise Date: [●] ___, [●]
   
  Issue Date: [●] ___, 20___

 

THIS PRE-FUNDED COMMON SHARE PURCHASE WARRANT (the “Warrant”) certifies that, for value received, _____________ or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after ________________, 20___ (the “Initial Exercise Date”) and until this Warrant is exercised in full (the “Termination Date”) but not thereafter, to subscribe for and purchase from BriaCell Therapeutics Corp., a British Columbia corporation (the “Company”), up to ______ Common Shares (as subject to adjustment hereunder, the “Warrant Shares”). The purchase price of one Common Share under this Warrant shall be equal to the Exercise Price, as defined in Section 2(b).

 

Section 1. Definitions. In addition to the terms defined elsewhere in this Warrant, the following terms have the meanings indicated in this Section 1:

 

Affiliate” means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 405 under the Securities Act.

 

“Business Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or Canada or any day on which banking institutions in the State of New York or Canada are authorized or required by law or other governmental action to close.

 

Commission” means the United States Securities and Exchange Commission.

 

Common Shares” means the common shares of the Company, no par value per share, and any other class of securities into which such securities may hereafter be reclassified or changed.

 

Common Share Equivalents” means any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire at any time Common Shares, including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Shares.

 

Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

 

Liens” means a lien, charge pledge, security interest, encumbrance, right of first refusal, preemptive right or other restriction.

 

Person” means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.

 

 Ex. A-1  
 

 

Proceeding” means an action, claim, suit, investigation or proceeding (including, without limitation, an informal investigation or partial proceeding, such as a deposition), whether commenced or threatened.

 

Registration Statement” means the Company’s registration statement on Form F-1 (File No. 333-234292).

 

Rule 144” means Rule 144 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as such Rule.

 

Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

 

Trading Day” means a day on which the Common Shares are traded on a Trading Market, provided however, that if a Trading Day is not a Business Day, then “Trading Day” shall mean the next following Business Day.

 

Trading Market” means any of the following markets or exchanges on which the Common Shares are listed or quoted for trading on the date in question: the NYSE American, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market, or the New York Stock Exchange (or any successors to any of the foregoing).

 

Transfer Agent” means Computershare Investor Services Inc., with a mailing address of 3rd Floor, 510 Burrard Street, Vancouver, British Columbia V6C 3B9, telephone number of (604) 661-9474 and a facsimile number of (604) 661-9401, and any successor transfer agent of the Company.

 

Warrants” means this Warrant and other Pre-Funded Common Share Purchase Warrants issued by the Company pursuant to the Registration Statement.

 

Section 2. Exercise.

 

a) Exercise of the purchase rights represented by this Warrant may be made, in whole or in part, at any time or times on or after the Initial Exercise Date and on or before the Termination Date by delivery to the Company of a duly executed facsimile copy (or e-mail attachment) of the Notice of Exercise in the form annexed hereto (the “Notice of Exercise”). Within the earlier of (i) two (2) Trading Days and (ii) the number of Trading Days comprising the Standard Settlement Period (as defined in Section 2(d)(i) herein) following the date of exercise as aforesaid, the Holder shall deliver to the Company the aggregate Exercise Price for the Warrant Shares specified in the applicable Notice of Exercise by wire transfer or cashier’s check drawn on a United States bank unless the cashless exercise procedure specified in Section 2(c) below is specified in the applicable Notice of Exercise. No ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise form be required. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company until the Holder has purchased all of the Warrant Shares available hereunder and the Warrant has been exercised in full, in which case, the Holder shall surrender this Warrant to the Company for cancellation within three (3) Trading Days of the date on which the final Notice of Exercise is delivered to the Company. Partial exercises of this Warrant resulting in purchases of a portion of the total number of Warrant Shares available hereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable hereunder in an amount equal to the applicable number of Warrant Shares purchased. The Holder and the Company shall maintain records showing the number of Warrant Shares purchased and the date of such purchases. The Company shall deliver any objection to any Notice of Exercise within one (1) Trading Day of receipt of such notice. The Holder and any assignee, by acceptance of this Warrant, acknowledge and agree that, by reason of the provisions of this paragraph, following the purchase of a portion of the Warrant Shares hereunder, the number of Warrant Shares available for purchase hereunder at any given time may be less than the amount stated on the face hereof.

 

 Ex. A-2  
 

 

b) Exercise Price. The aggregate exercise price of this Warrant, except for a nominal exercise price of $0.01 per Warrant Share, was pre-funded to the Company on or prior to the Initial Exercise Date and, consequently, no additional consideration (other than the nominal exercise price of $0.01 per Warrant Share) shall be required to be paid by the Holder to any Person to effect any exercise of this Warrant. The Holder shall not be entitled to the return or refund of all, or any portion, of such pre-paid aggregate exercise price under any circumstance or for any reason whatsoever, including in the event this Warrant shall not have been exercised prior to the Termination Date. The remaining unpaid exercise price per Common Share under this Warrant shall be $0.01, subject to adjustment hereunder (the “Exercise Price”).

 

c) Cashless Exercise. If at the time of exercise hereof there is no effective registration statement registering the Warrant Shares, or the prospectus contained therein is not available for the issuance of the Warrant Shares to the Holder, then this Warrant may also be exercised, in whole or in part, at such time by means of a “cashless exercise” in which the Holder shall be entitled to receive a number of Warrant Shares equal to the quotient obtained by dividing [(A-B) (X)] by (A), where:

 

  (A) = the last VWAP immediately preceding the time of delivery of the Notice of Exercise giving rise to the applicable “cashless exercise”, as set forth in the applicable Notice of Exercise (to clarify, the “last VWAP” will be the last VWAP as calculated over an entire Trading Day such that, in the event that this Warrant is exercised at a time that the Trading Market is open, the prior Trading Day’s VWAP shall be used in this calculation);
     
  (B) = the Exercise Price of this Warrant, as adjusted hereunder; and
     
  (X) = the number of Warrant Shares that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means of a cash exercise rather than a cashless exercise.

 

Notwithstanding anything herein to the contrary, the Company shall not be required to make any cash payments or net cash settlement to the Holder in lieu of delivery of the Warrant Shares. If Warrant Shares are issued in such a cashless exercise, the parties acknowledge and agree that in accordance with Section 3(a)(9) of the Securities Act, the Warrant Shares shall take on the registered characteristics of the Warrants being exercised. The Company agrees not to take any position contrary to this Section 2(c).

 

VWAP” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Common Shares are then listed or quoted for trading on a Trading Market, the daily volume weighted average price of the Common Shares for such date (or the nearest preceding date) on the Trading Market on which the Common Shares are then listed or quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if the Common Shares are then quoted for trading on the OTCQB or OTCQX operated by OTC Markets Group, the volume weighted average price of the Common Shares for such date (or the nearest preceding date) on OTCQB or OTCQX as applicable, (c) if the Common Shares are then quoted for trading on the Pink Open Market operated by OTC Markets Group (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per Common Share reported on the Pink Open Market, or (d) in all other cases, the fair market value of a Common Share as determined by an independent appraiser selected in good faith by the holders of a majority in interest of the Warrants then outstanding and reasonably acceptable to the Company, the fees and expenses of which shall be paid by the Company.

 

 Ex. A-3  
 

 

d) Mechanics of Exercise.

 

i. Delivery of Warrant Shares Upon Exercise. The Company shall cause the Warrant Shares purchased hereunder to be transmitted by the Transfer Agent to the Holder by crediting the account of the Holder’s or its designee’s balance account with The Depository Trust Company through its Deposit or Withdrawal at Custodian system (the “DWAC”) if the Company is then a participant in such system and either (A) there is an effective registration statement permitting the issuance of the Warrant Shares to or resale of the Warrant Shares by the Holder or (B) this Warrant is being exercised via cashless exercise, and otherwise by physical delivery of a certificate, registered in the Company’s share register in the name of the Holder or its designee, for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise to the address specified by the Holder in the Notice of Exercise by the date that is the earlier of (i) two (2) Trading Days and (ii) the number of Trading Days comprising the Standard Settlement Period after the delivery to the Company of the Notice of Exercise (such date, the “Warrant Share Delivery Date”). Upon delivery of the Notice of Exercise, the Holder shall be deemed for all corporate purposes to have become the Holder of record of the Warrant Shares with respect to which this Warrant has been exercised, irrespective of the date of delivery of the Warrant Shares, provided that payment of the aggregate Exercise Price (other than in the case of a cashless exercise) is received within the earlier of (i) two (2) Trading Days and (ii) the number of Trading Days comprising the Standard Settlement Period following delivery of the Notice of Exercise. If the Company fails for any reason to deliver to the Holder the Warrant Shares subject to a Notice of Exercise by the Warrant Share Delivery Date, the Company shall pay to the Holder, in cash, as liquidated damages and not as a penalty, for each $1,000 of Warrant Shares subject to such exercise (based on the VWAP of the Common Shares on the date of the applicable Notice of Exercise), $10 per Trading Day (increasing to $20 per Trading Day on the fifth Trading Day after such liquidated damages begin to accrue) for each Trading Day after such Warrant Share Delivery Date until such Warrant Shares are delivered to said Holder or the Holder rescinds such exercise. The Company agrees to maintain a transfer agent that is a participant in the Fast Automated Securities Transfer or FAST program so long as this Warrant remains outstanding and exercisable. As used herein, “Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, on the Company’s primary Trading Market with respect to the Common Shares as in effect on the date of delivery of the Notice of Exercise. Notwithstanding the foregoing, with respect to any Notice(s) of Exercise delivered on or prior to 12:00 p.m. (New York City time) on the Initial Exercise Date, which may be delivered at any time after the time of execution of the Underwriting Agreement, dated _____________, 20___ between the Company and ThinkEquity, a division of Fordham Financial Management, Inc., the Company agrees to deliver the Warrant Shares subject to such notice(s) by 4:00 p.m. (New York City time) on the Initial Exercise Date.

 

ii. Delivery of New Warrants Upon Exercise. If this Warrant shall have been exercised in part, the Company shall, at the request of a Holder and upon surrender of this Warrant certificate, at the time of delivery of the Warrant Shares, deliver to the Holder a new Warrant evidencing the rights of the Holder to purchase the unpurchased Warrant Shares called for by this Warrant, which new Warrant shall in all other respects be identical with this Warrant.

 

iii. Rescission Rights. If the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares pursuant to Section 2(d)(i) by the Warrant Share Delivery Date, then the Holder will have the right to rescind such exercise.

 

 Ex. A-4  
 

 

iv. Compensation for Buy-In on Failure to Timely Deliver Warrant Shares Upon Exercise. In addition to any other rights available to the Holder, if the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares in accordance with the provisions of Section 2(d)(i) above pursuant to an exercise on or before the Warrant Share Delivery Date, and if after such date the Holder is required by its broker to purchase (in an open market transaction or otherwise) or the Holder’s brokerage firm otherwise purchases, Common Shares to deliver in satisfaction of a sale by the Holder of the Warrant Shares which the Holder anticipated receiving upon such exercise (a “Buy-In”), then the Company shall (A) pay in cash to the Holder the amount, if any, by which (x) the Holder’s total purchase price (including brokerage commissions, if any) for the Common Shares so purchased exceeds (y) the amount obtained by multiplying (1) the number of Warrant Shares that the Company was required to deliver to the Holder in connection with the exercise at issue by (2) the price at which the sell order giving rise to such purchase obligation was executed, and (B) at the option of the Holder, either reinstate the portion of the Warrant and equivalent number of Warrant Shares for which such exercise was not honored (in which case such exercise shall be deemed rescinded) or deliver to the Holder the number of Common Shares that would have been issued had the Company timely complied with its exercise and delivery obligations hereunder. For example, if the Holder purchases Common Shares having a total purchase price of $11,000 to cover a Buy-In with respect to an attempted exercise of Common Shares with an aggregate sale price giving rise to such purchase obligation of $10,000, under clause (A) of the immediately preceding sentence the Company shall be required to pay the Holder $1,000. The Holder shall provide the Company written notice indicating the amounts payable to the Holder in respect of the Buy-In and, upon request of the Company, evidence of the amount of such loss. Nothing herein shall limit a Holder’s right to pursue any other remedies available to it hereunder, at law or in equity including, without limitation, a decree of specific performance and/or injunctive relief with respect to the Company’s failure to timely deliver Common Shares upon exercise of the Warrant as required pursuant to the terms hereof.

 

v. No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall, at its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Exercise Price or round up to the next whole share.

 

vi. Charges, Taxes and Expenses. Issuance of Warrant Shares shall be made without charge to the Holder for any issue or transfer tax or other incidental expense in respect of the issuance of such Warrant Shares, all of which taxes and expenses shall be paid by the Company, and such Warrant Shares shall be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided, however, that in the event that Warrant Shares are to be issued in a name other than the name of the Holder, this Warrant when surrendered for exercise shall be accompanied by the Assignment Form attached hereto duly executed by the Holder and the Company may require, as a condition thereto, the payment of a sum sufficient to reimburse it for any transfer tax incidental thereto. The Company shall pay all Transfer Agent fees required for same-day processing of any Notice of Exercise and all fees to the Depository Trust Company (or another established clearing corporation performing similar functions) required for same-day electronic delivery of the Warrant Shares.

 

vii. Closing of Books. The Company shall not close its shareholder books or records in any manner which prevents the timely exercise of this Warrant, pursuant to the terms hereof.

 

 Ex. A-5  
 

 

e) Holder’s Exercise Limitations. The Company shall not effect any exercise of this Warrant, and a Holder shall not have the right to exercise any portion of this Warrant, pursuant to Section 2 or otherwise, to the extent that after giving effect to such issuance after exercise as set forth on the applicable Notice of Exercise, the Holder (together with the Holder’s Affiliates, and any other Persons acting as a group together with the Holder or any of the Holder’s Affiliates (such Persons, “Attribution Parties”)), would beneficially own in excess of the Beneficial Ownership Limitation (as defined below). For purposes of the foregoing sentence, the number of Common Shares beneficially owned by the Holder and its Affiliates and Attribution Parties shall include the number of Common Shares issuable upon exercise of this Warrant with respect to which such determination is being made, but shall exclude the number of Common Shares which would be issuable upon (i) exercise of the remaining, non-exercised portion of this Warrant beneficially owned by the Holder or any of its Affiliates or Attribution Parties and (ii) exercise or conversion of the unexercised or non-converted portion of any other securities of the Company (including, without limitation, any other Common Share Equivalents) subject to a limitation on conversion or exercise analogous to the limitation contained herein beneficially owned by the Holder or any of its Affiliates or Attribution Parties. Except as set forth in the preceding sentence, for purposes of this Section 2(e), beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder, it being acknowledged by the Holder that the Company is not representing to the Holder that such calculation is in compliance with Section 13(d) of the Exchange Act and the Holder is solely responsible for any schedules required to be filed in accordance therewith. To the extent that the limitation contained in this Section 2(e) applies, the determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates and Attribution Parties) and of which portion of this Warrant is exercisable shall be in the sole discretion of the Holder, and the submission of a Notice of Exercise shall be deemed to be the Holder’s determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates and Attribution Parties) and of which portion of this Warrant is exercisable, in each case subject to the Beneficial Ownership Limitation, and the Company shall have no obligation to verify or confirm the accuracy of such determination. In addition, a determination as to any group status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder. For purposes of this Section 2(e), in determining the number of outstanding Common Shares, a Holder may rely on the number of outstanding Common Shares as reflected in (A) the Company’s most recent periodic or annual report filed with the Commission, as the case may be, (B) a more recent public announcement by the Company or (C) a more recent written notice by the Company or the Transfer Agent setting forth the number of Common Shares outstanding. Upon the written or oral request of a Holder, the Company shall within two Trading Days confirm orally and in writing to the Holder the number of Common Shares then outstanding. In any case, the number of outstanding Common Shares shall be determined after giving effect to the conversion or exercise of securities of the Company, including this Warrant, by the Holder or its Affiliates or Attribution Parties since the date as of which such number of outstanding Common Shares was reported. The “Beneficial Ownership Limitation” shall be 4.99% (or, upon election by a Holder prior to the issuance of any Warrants, 9.99%) of the number of Common Shares outstanding immediately after giving effect to the issuance of Common Shares issuable upon exercise of this Warrant. The Holder, upon notice to the Company, may increase or decrease the Beneficial Ownership Limitation provisions of this Section 2(e), provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of Common Shares outstanding immediately after giving effect to the issuance of Common Shares upon exercise of this Warrant held by the Holder and the provisions of this Section 2(e) shall continue to apply. Any increase in the Beneficial Ownership Limitation will not be effective until the 61st day after such notice is delivered to the Company. The provisions of this paragraph shall be construed and implemented in a manner otherwise than in strict conformity with the terms of this Section 2(e) to correct this paragraph (or any portion hereof) which may be defective or inconsistent with the intended Beneficial Ownership Limitation herein contained or to make changes or supplements necessary or desirable to properly give effect to such limitation. The limitations contained in this paragraph shall apply to a successor holder of this Warrant.

 

Section 3. Certain Adjustments.

 

a) Stock Dividends and Splits. If the Company, at any time while this Warrant is outstanding: (i) pays a stock dividend or otherwise makes a distribution or distributions on its Common Shares or any other equity or equity equivalent securities payable in Common Shares (which, for avoidance of doubt, shall not include any Common Shares issued by the Company upon exercise of this Warrant), (ii) subdivides outstanding Common Shares into a larger number of shares, (iii) combines (including by way of reverse share split or consolidation) outstanding Common Shares into a smaller number of shares, or (iv) issues by reclassification of Common Shares any shares of the Company, then in each case the Exercise Price shall be multiplied by a fraction of which the numerator shall be the number of Common Shares (excluding treasury shares, if any) outstanding immediately before such event and of which the denominator shall be the number of Common Shares outstanding immediately after such event, and the number of shares issuable upon exercise of this Warrant shall be proportionately adjusted such that the aggregate Exercise Price of this Warrant shall remain unchanged. Any adjustment made pursuant to this Section 3(a) shall become effective immediately after the record date for the determination of shareholders entitled to receive such dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or re-classification.

 

 Ex. A-6  
 

 

b) Subsequent Rights Offerings. In addition to any adjustments pursuant to Section 3(a) above, if at any time the Company grants, issues or sells any Common Share Equivalents or rights to purchase shares, warrants, securities or other property pro rata to the record holders of Common Shares (the “Purchase Rights”), then the Holder will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the Holder could have acquired if the Holder had held the number of Common Shares acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date on which a record is taken for the grant, issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record holders of Common Shares are to be determined for the grant, issue or sale of such Purchase Rights (provided, however, to the extent that the Holder’s right to participate in any such Purchase Right would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Purchase Right to such extent (or beneficial ownership of such Common Shares as a result of such Purchase Right to such extent) and such Purchase Right to such extent shall be held in abeyance for the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).

 

c) Pro Rata Distributions. During such time as this Warrant is outstanding, if the Company shall declare or make any dividend or other distribution of its assets (or rights to acquire its assets) to holders of Common Shares, by way of return of capital or otherwise (including, without limitation, any distribution of cash, shares or other securities, property or options by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar transaction) (a “Distribution”), at any time after the issuance of this Warrant, then, in each such case, the Holder shall be entitled to participate in such Distribution to the same extent that the Holder would have participated therein if the Holder had held the number of Common Shares acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date of which a record is taken for such Distribution, or, if no such record is taken, the date as of which the record holders of Common Shares are to be determined for the participation in such Distribution (provided, however, to the extent that the Holder’s right to participate in any such Distribution would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Distribution to such extent (or in the beneficial ownership of any Common Shares as a result of such Distribution to such extent) and the portion of such Distribution shall be held in abeyance for the benefit of the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).

 

 Ex. A-7  
 

 

d) Fundamental Transaction. If, at any time while this Warrant is outstanding, (i) the Company, directly or indirectly, in one or more related transactions effects any merger or amalgamation or consolidation of the Company with or into another Person, (ii) the Company, directly or indirectly, effects any sale, lease, license, assignment, transfer, conveyance or other disposition of all or substantially all of its assets in one or a series of related transactions, (iii) any, direct or indirect, purchase offer, tender offer or exchange offer (whether by the Company or another Person) is completed pursuant to which holders of Common Shares are permitted to sell, tender or exchange their shares for other securities, cash or property and has been accepted by the holders of 50% or more of the outstanding Common Shares, (iv) the Company, directly or indirectly, in one or more related transactions effects any reclassification, reorganization or recapitalization of the Common Shares or any compulsory share exchange pursuant to which the Common Shares are effectively converted into or exchanged for other securities, cash or property, or (v) the Company, directly or indirectly, in one or more related transactions consummates a share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off or scheme of arrangement) with another Person or group of Persons whereby such other Person or group acquires more than 50% of the outstanding Common Shares (not including any Common Shares held by the other Person or other Persons making or party to, or associated or affiliated with the other Persons making or party to, such share purchase agreement or other business combination) (each a “Fundamental Transaction”), then, upon any subsequent exercise of this Warrant, the Holder shall have the right to receive, for each Warrant Share that would have been issuable upon such exercise immediately prior to the occurrence of such Fundamental Transaction, at the option of the Holder (without regard to any limitation in Section 2(e) on the exercise of this Warrant), the number of Common Shares of the successor or acquiring corporation or of the Company, if it is the surviving corporation or is otherwise the continuing corporation, and any additional consideration (the “Alternate Consideration”) receivable as a result of such Fundamental Transaction by a holder of the number of Common Shares for which this Warrant is exercisable immediately prior to such Fundamental Transaction (without regard to any limitation in Section 2(e) on the exercise of this Warrant). For purposes of any such exercise, the determination of the Exercise Price shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one Common Share in such Fundamental Transaction, and the Company shall apportion the Exercise Price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of Common Shares are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holder shall be given the same choice as to the Alternate Consideration it receives upon any exercise of this Warrant following such Fundamental Transaction. The Company shall cause any successor entity in a Fundamental Transaction in which the Company is not the survivor (the “Successor Entity”) to assume in writing all of the obligations of the Company under this Warrant in accordance with the provisions of this Section 3(d) pursuant to written agreements prior to such Fundamental Transaction and shall, at the option of the Holder, deliver to the Holder in exchange for this Warrant a security of the Successor Entity evidenced by a written instrument substantially similar in form and substance to this Warrant which is exercisable for a corresponding number of shares or other securities of such Successor Entity (or its parent entity) equivalent to the Common Shares acquirable and receivable upon exercise of this Warrant (without regard to any limitations on the exercise of this Warrant) prior to such Fundamental Transaction, and with an exercise price which applies the exercise price hereunder to such shares of or other securities (but taking into account the relative value of the Common Shares pursuant to such Fundamental Transaction and the value of such shares or securities, such number of shares or securities and such exercise price being for the purpose of protecting the economic value of this Warrant immediately prior to the consummation of such Fundamental Transaction). Upon the occurrence of any such Fundamental Transaction, the Successor Entity shall succeed to, and be substituted for (so that from and after the date of such Fundamental Transaction, the provisions of this Warrant referring to the “Company” shall refer instead to the Successor Entity), and may exercise every right and power of the Company and shall assume all of the obligations of the Company under this Warrant with the same effect as if such Successor Entity had been named as the Company herein.

 

e) Calculations. All calculations under this Section 3 shall be made to the nearest cent or the nearest 1/100th of a share, as the case may be. For purposes of this Section 3, the number of Common Shares deemed to be issued and outstanding as of a given date shall be the sum of the number of Common Shares (excluding treasury shares, if any) issued and outstanding.

 

f) Notice to Holder.

 

i. Adjustment to Exercise Price. Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3, the Company shall promptly deliver to the Holder by facsimile or email a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts requiring such adjustment.

 

 Ex. A-8  
 

 

ii. Notice to Allow Exercise by Holder. If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Common Shares, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Common Shares, (C) the Company shall authorize the granting to all holders of the Common Shares rights or warrants to subscribe for or purchase any shares of the Company or of any rights, (D) the approval of any shareholders of the Company shall be required in connection with any reclassification of the Common Shares, any consolidation or merger, amalgamation or arrangement to which the Company is a party, any sale or transfer of all or substantially all of the assets of the Company, or any compulsory share exchange whereby the Common Shares are converted into other securities, cash or property, or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be delivered by facsimile or email to the Holder at its last facsimile number or email address as it shall appear upon the Warrant Register of the Company, at least 20 calendar days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Common Shares of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, amalgamation, arrangement, sale, transfer or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Common Shares of record shall be entitled to exchange their Common Shares for securities, cash or other property deliverable upon such reclassification, consolidation, merger, amalgamation, arrangement sale, transfer or share exchange; provided that the failure to deliver such notice or any defect therein or in the delivery thereof shall not affect the validity of the corporate action required to be specified in such notice. To the extent that any notice provided in this Warrant constitutes, or contains, material, non-public information regarding the Company or any of its subsidiaries (the “Subsidiaries”), the Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form 8-K or a Report of Foreign Private Issuer on Form 6-K. The Holder shall remain entitled to exercise this Warrant during the period commencing on the date of such notice to the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.

 

Section 4. Transfer of Warrant.

 

a) Transferability. This Warrant and all rights hereunder are transferable, in whole or in part, upon surrender of this Warrant at the principal office of the Company or its designated agent, together with a written assignment of this Warrant substantially in the form attached hereto duly executed by the Holder or its agent or attorney and funds sufficient to pay any transfer taxes payable upon the making of such transfer. Upon such surrender and, if required, such payment, the Company shall execute and deliver a new Warrant or Warrants in the name of the assignee or assignees, as applicable, and in the denomination or denominations specified in such instrument of assignment, and shall issue to the assignor a new Warrant evidencing the portion of this Warrant not so assigned, and this Warrant shall promptly be cancelled. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company unless the Holder has assigned this Warrant in full, in which case, the Holder shall surrender this Warrant to the Company within three (3) Trading Days of the date on which the Holder delivers an assignment form to the Company assigning this Warrant in full. This Warrant, if properly assigned in accordance herewith, may be exercised by a new holder for the purchase of Warrant Shares without having a new Warrant issued.

 

b) New Warrants. This Warrant may be divided or combined with other Warrants upon presentation hereof at the aforesaid office of the Company, together with a written notice specifying the names and denominations in which new Warrants are to be issued, signed by the Holder or its agent or attorney. Subject to compliance with Section 4(a), as to any transfer which may be involved in such division or combination, the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or Warrants to be divided or combined in accordance with such notice. All Warrants issued on transfers or exchanges shall be dated the original Initial Exercise Date of this Warrant and shall be identical with this Warrant except as to the number of Warrant Shares issuable pursuant thereto.

 

c) Warrant Register. The Company shall register this Warrant, upon records to be maintained by the Company for that purpose (the “Warrant Register”), in the name of the record Holder hereof from time to time. The Company may deem and treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary.

 

 Ex. A-9  
 

 

Section 5. Miscellaneous.

 

a) No Rights as Shareholder Until Exercise. This Warrant does not entitle the Holder to any voting rights, dividends or other rights as a shareholder of the Company prior to the exercise hereof as set forth in Section 2(d)(i), except as expressly set forth in Section 3.

 

b) Loss, Theft, Destruction or Mutilation of Warrant. The Company covenants that upon receipt by the Company of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any stock certificate relating to the Warrant Shares, and in case of loss, theft or destruction, of indemnity or security reasonably satisfactory to it (which shall in no event include the posting of any bond), and upon surrender and cancellation of such Warrant or stock certificate, if mutilated, the Company shall make and deliver a new Warrant or stock certificate of like tenor and dated as of such cancellation, in lieu of such Warrant or stock certificate.

 

c) Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Business Day, then, such action may be taken or such right may be exercised on the next succeeding Business Day.

 

d) Authorized Shares.

 

The Company covenants that, during the period the Warrant is outstanding, it will reserve from its authorized and unissued Common Shares a sufficient number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant. The Company further covenants that its issuance of this Warrant shall constitute full authority to its officers who are charged with the duty of issuing the necessary Warrant Shares upon the exercise of the purchase rights under this Warrant. The Company shall take all such reasonable action as may be necessary to assure that such Warrant Shares may be issued as provided herein without violation of any applicable law or regulation, or of any requirements of the Trading Market upon which the Common Shares may be listed. The Company covenants that all Warrant Shares which may be issued upon the exercise of the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for such Warrant Shares in accordance herewith, be duly authorized, validly issued, fully paid and non-assessable and free from all taxes, liens and charges created by the Company in respect of the issue thereof (other than taxes in respect of any transfer occurring contemporaneously with such issue).

 

Except and to the extent as waived or consented to by the Holder, the Company shall not by any action, including, without limitation, amending its certificate of incorporation or through any reorganization, transfer of assets, consolidation, merger, amalgamation, arrangement dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate to protect the rights of Holder as set forth in this Warrant against impairment. Without limiting the generality of the foregoing, the Company shall (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise immediately prior to such increase in par value, (ii) take all such action as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and non-assessable Warrant Shares upon the exercise of this Warrant and (iii) use commercially reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof, as may be, necessary to enable the Company to perform its obligations under this Warrant.

 

Before taking any action which would result in an adjustment in the number of Warrant Shares for which this Warrant is exercisable or in the Exercise Price, the Company shall obtain all such authorizations or exemptions thereof, or consents thereto, as may be necessary from any public regulatory body or bodies having jurisdiction thereof.

 

 Ex. A-10  
 

 

e) Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Warrant shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflict of laws thereof. Each party agrees that all legal Proceedings concerning the interpretation, enforcement and defense of this Warrant shall be commenced in the state and federal courts sitting in the City of New York, Borough of Manhattan (the “New York Courts”). Each party hereto hereby irrevocably submits to the exclusive jurisdiction of the New York Courts for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including with respect to the enforcement of any provision hereunder), and hereby irrevocably waives, and agrees not to assert in any suit, action or Proceeding, any claim that it is not personally subject to the jurisdiction of such New York Courts, or such New York Courts are improper or inconvenient venue for such Proceeding. If any party shall commence an action or Proceeding to enforce any provisions of this Warrant, then the prevailing party in such action or Proceeding shall be reimbursed by the other party for its attorneys’ fees and other costs and expenses incurred in the investigation, preparation and prosecution of such action or Proceeding.

 

f) Restrictions. The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant, if not registered, and the Holder does not utilize cashless exercise, will have restrictions upon resale imposed by state and federal securities laws.

 

g) Nonwaiver and Expenses. No course of dealing or any delay or failure to exercise any right hereunder on the part of Holder shall operate as a waiver of such right or otherwise prejudice the Holder’s rights, powers or remedies. Without limiting any other provision of this Warrant, if the Company willfully and knowingly fails to comply with any provision of this Warrant, which results in any material damages to the Holder, the Company shall pay to the Holder such amounts as shall be sufficient to cover any costs and expenses including, but not limited to, reasonable attorneys’ fees, including those of appellate Proceedings, incurred by the Holder in collecting any amounts due pursuant hereto or in otherwise enforcing any of its rights, powers or remedies hereunder.

 

h) Notices. Any and all notices or other communications or deliveries to be provided by the Holders hereunder including, without limitation, any Notice of Exercise, shall be in writing and delivered personally, by facsimile or by e-mail, or sent by a nationally recognized overnight courier service, addressed to the Company, at 300 – 235 15th Street, West Vancouver, British Columbia, V7T 2X1, Attention: Dr. William V. Williams, facsimile number: (604) 921-1898, email address: williams@briacell.com, or such other facsimile number, email address or address as the Company may specify for such purposes by notice to the Holders. Any and all notices or other communications or deliveries to be provided by the Company hereunder shall be in writing and delivered personally, by facsimile, or sent by a nationally recognized overnight courier service addressed to each Holder at the facsimile number or address of such Holder appearing on the books of the Company. Any notice or other communication or deliveries hereunder shall be deemed given and effective on the earliest of (i) the time of transmission, if such notice or communication is delivered via facsimile at the facsimile number or e-mail at the e-mail address set forth in this Section prior to 5:30 p.m. (New York City time) on any date, (ii) the next Trading Day after the date of transmission, if such notice or communication is delivered via facsimile at the facsimile number or e-mail at the e-mail address set forth in this Section on a day that is not a Trading Day or later than 5:30 p.m. (New York City time) on any Trading Day, (iii) the second Trading Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service, or (iv) upon actual receipt by the party to whom such notice is required to be given.

 

i) Limitation of Liability. No provision hereof, in the absence of any affirmative action by the Holder to exercise this Warrant to purchase Warrant Shares, and no enumeration herein of the rights or privileges of the Holder, shall give rise to any liability of the Holder for the purchase price of any Common Shares or as a shareholder of the Company, whether such liability is asserted by the Company or by creditors of the Company.

 

j) Remedies. The Holder, in addition to being entitled to exercise all rights granted by law, including recovery of damages, will be entitled to specific performance of its rights under this Warrant. The Company agrees that monetary damages would not be adequate compensation for any loss incurred by reason of a breach by it of the provisions of this Warrant and hereby agrees to waive and not to assert the defense in any action for specific performance that a remedy at law would be adequate.

 

k) Successors and Assigns. Subject to applicable securities laws, this Warrant and the rights and obligations evidenced hereby shall inure to the benefit of and be binding upon the successors and permitted assigns of the Company and the successors and permitted assigns of Holder. The provisions of this Warrant are intended to be for the benefit of any Holder from time to time of this Warrant and shall be enforceable by the Holder or holder of Warrant Shares.

 

l) Amendment. This Warrant may be modified or amended or the provisions hereof waived with the written consent of the Company, on the one hand, and the Holder on the other hand.

 

m) Severability. Wherever possible, each provision of this Warrant shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Warrant shall be prohibited by or invalid under applicable law, such provision shall be ineffective to the extent of such prohibition or invalidity, without invalidating the remainder of such provisions or the remaining provisions of this Warrant.

 

n) Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant.

 

********************

 

(Signature Page Follows)

 

 Ex. A-11  
 

 

IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its officer thereunto duly authorized as of the date first above indicated.

 

  briacell therapeutics corp.
     
  By:                        
  Name:  
  Title:  

 

 Ex. A-12  
 

 

NOTICE OF EXERCISE

 

To: BRIACELL THERAPEUTICS CORP.

 

(1) The undersigned hereby elects to purchase ________ Warrant Shares of the Company pursuant to the terms of the attached Warrant (only if exercised in full), and tenders herewith payment of the exercise price in full, together with all applicable transfer taxes, if any.

 

(2) Payment shall take the form of (check applicable box):

 

  [  ] in lawful money of the United States; or
     
  [  ] if permitted the cancellation of such number of Warrant Shares as is necessary, in accordance with the formula set forth in subsection 2(c), to exercise this Warrant with respect to the maximum number of Warrant Shares purchasable pursuant to the cashless exercise procedure set forth in subsection 2(c).

 

(3) Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below:

 

____________________________________

 

The Warrant Shares shall be delivered to the following DWAC Account Number:

 

____________________________________

 

____________________________________

 

[SIGNATURE OF HOLDER]

 

Name of Investing Entity: ___________________________________________________________________________

 

Signature of Authorized Signatory of Investing Entity: _____________________________________________________

 

Name of Authorized Signatory: _______________________________________________________________________

 

Title of Authorized Signatory: ________________________________________________________________________

 

Date: ___________________________________________________________________________________________

 

 Ex. A-13  
 

 

ASSIGNMENT FORM

 

(To assign the foregoing Warrant, execute this form and supply required information. Do not use this form to purchase shares.)

 

FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby assigned to

 

Name:  
  (Please Print)
   
Address::  
  (Please Print)
   
Phone Number:  
   
Email Address:  
   
Dated:   ,    
     
Holder’s Signature:    
     
Holder’s Address:    
     
     

 

 Ex. A-14  
 

 

Exhibit B

 

Form of Representative’s Warrant Agreement

 

THE REGISTERED HOLDER OF THIS WARRANT BY ITS ACCEPTANCE HEREOF, AGREES THAT IT WILL NOT SELL, TRANSFER OR ASSIGN THIS WARRANT EXCEPT AS HEREIN PROVIDED AND THE REGISTERED HOLDER OF THIS WARRANT AGREES THAT IT WILL NOT SELL, TRANSFER, ASSIGN, PLEDGE OR HYPOTHECATE THIS WARRANT: (A) FOR A PERIOD OF ONE HUNDRED EIGHTY DAYS FOLLOWING THE EFFECTIVE DATE (DEFINED BELOW) TO ANYONE OTHER THAN (I) THINKEQUITY, A DIVISION OF FORDHAM FINANCIAL MANAGEMENT, INC., OR AN UNDERWRITER OR A SELECTED DEALER IN CONNECTION WITH THE OFFERING, OR (II) A BONA FIDE OFFICER OR PARTNER OF THINKEQUITY, A DIVISION OF FORDHAM FINANCIAL MANAGEMENT, INC., OR OF ANY SUCH UNDERWRITER OR SELECTED DEALER; AND (B) FOR SO LONG AS THE COMMON SHARES OF BRIACELL THERAPEUTICS CORP. ARE LISTED ON THE TSX VENTURE EXCHANGE, TO ANYONE OTHER THAN (I) AN AFFILIATE OR EMPLOYEE (OR AN AFFILIATE OF SUCH EMPLOYEE) OF [NAME OF UNDERWRITER] WITHIN THE MEANING OF THE POLICIES THE TSX VENTURE EXCHANGE OR (II) AN UNDERWRITER OR A SELECTED DEALER IN CONNECTION WITH THE OFFERING OR AN OFFICER OR PARTNER THEREOF.

 

THIS WARRANT IS NOT EXERCISABLE PRIOR TO [________________] [DATE THAT IS SIX MONTHS FROM THE EFFECTIVE DATE OF THE OFFERING]. VOID AFTER 5:00 P.M., EASTERN TIME, [___________________] [DATE THAT IS FIVE YEARS FROM THE EFFECTIVE DATE OF THE OFFERING].

 

WARRANT TO PURCHASE COMMON SHARES

 

BRIACELL THERAPEUTICS CORP.

 

Warrant Shares: _______

 

Initial Exercise Date: ______, 2020

 

THIS WARRANT TO PURCHASE COMMON SHARES (the “Warrant”) certifies that, for value received, ______________________________ or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after ____, 20___ (the “Initial Exercise Date”) and, in accordance with FINRA Rule 5110(f)(2)(G)(i), at or prior to at 5:00 p.m. (New York City time) on the date that is five (5) years following the Effective Date (the “Termination Date”) but not thereafter, to subscribe for and purchase from BriaCell Therapeutics Corp., a British Columbia corporation (the “Company”), up to __________ Common Shares, with no par value per share, of the Company (the “Warrant Shares”), as subject to adjustment hereunder. The purchase price of one Warrant Share under this Warrant shall be equal to the Exercise Price, as defined in Section 2(b).

 

 Ex. B-1  
 

 

Section 1. Definitions. In addition to the terms defined elsewhere in this Agreement, the following terms have the meanings indicated in this Section 1:

 

Affiliate” means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 405 under the Securities Act.

 

Business Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or Canada or any day on which banking institutions in the State of New York or Canada are authorized or required by law or other governmental action to close.

 

Commission” means the United States Securities and Exchange Commission.

 

Common Shares” means the common shares of the Company, with no par value per share, and any other class of securities into which such securities may hereafter be reclassified or changed.

 

Common Share Equivalents” means any securities of the Company or its subsidiaries which would entitle the holder thereof to acquire at any time Common Shares, including, without limitation, any debt, preferred shares, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Shares.

 

Effective Date” means the effective date of the registration statement on Form F-1 (File No. 333-234292), including any related prospectus or prospectuses, for the registration of the Warrant and the Warrant Shares under the Securities Act, that the Company has filed with the Commission.

 

Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

 

Offering” means the offering of securities pursuant to which this Warrant was issued.

 

Person” means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.

 

Rule 144” means Rule 144 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as such Rule.

 

Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

 

Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, on the Company’s primary Trading Market with respect to the Common Shares as in effect on the date of delivery of the Notice of Exercise.

 

Trading Day” means a day on which the Common Shares are traded on a Trading Market, provided however, that if a Trading Day is not a Business Day, then “Trading Day” shall mean the next following Business Day.

 

Trading Market” means any of the following markets or exchanges on which the Common Shares are listed or quoted for trading on the date in question: the NYSE American, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market, or the New York Stock Exchange (or any successors to any of the foregoing).

 

 Ex. B-2  
 

 

VWAP” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Common Shares are then listed or quoted for trading on a Trading Market, the daily volume weighted average price of the Common Shares for such date (or the nearest preceding date) on the Trading Market on which the Common Shares are then listed or quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if the Common Shares are then quoted for trading on the OTCQB or OTCQX operated by OTC Markets Group, the volume weighted average price of the Common Shares for such date (or the nearest preceding date) on the OTCQB or OTCQX as applicable, (c) if the Common Shares are then quoted for trading on the Pink Open Market operated by OTC Markets Group (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per Common Share reported on the Pink Open Market, or (d) in all other cases, the fair market value of a Common Share as determined by an independent appraiser selected in good faith by the Holder and reasonably acceptable to the Company, the fees and expenses of which shall be paid by the Company.Section 2. Exercise.a) Exercise of the purchase rights represented by this Warrant may be made, in whole or in part, at any time or times on or after the Initial Exercise Date and at or prior to 5:00 p.m. (New York City time) on the Termination Date by delivery to the Company (or such other office or agency of the Company as it may designate by notice in writing to the registered Holder at the address of the Holder appearing on the books of the Company) of a duly executed facsimile copy (or e-mail attachment) of the Notice of Exercise form annexed hereto. Within the earlier of (i) two (2) Trading Days and (ii) the number of Trading Days comprising the Standard Settlement Period following the date of exercise as aforesaid, the Holder shall deliver to the Company the aggregate Exercise Price for the Warrant Shares specified in the applicable Notice of Exercise by wire transfer or cashier’s check drawn on a United States bank unless the cashless exercise procedure specified in Section 2(c) below is specified in the applicable Notice of Exercise. No ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise form be required. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company until the Holder has purchased all of the Warrant Shares available hereunder and the Warrant has been exercised in full, in which case, the Holder shall surrender this Warrant to the Company for cancellation within five (5) Trading Days of the date the final Notice of Exercise is delivered to the Company. Partial exercises of this Warrant resulting in purchases of a portion of the total number of Warrant Shares available hereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable hereunder in an amount equal to the applicable number of Warrant Shares purchased. The Holder and the Company shall maintain records showing the number of Warrant Shares purchased and the date of such purchases. The Company shall deliver any objection to any Notice of Exercise within one (1) Business Days of receipt of such notice. The Holder and any assignee, by acceptance of this Warrant, acknowledge and agree that, by reason of the provisions of this paragraph, following the purchase of a portion of the Warrant Shares hereunder, the number of Warrant Shares available for purchase hereunder at any given time may be less than the amount stated on the face hereof.

 

 Ex. B-3  
 

 

b) Exercise Price. The exercise price per Common Share under this Warrant shall be $_______1, subject to adjustment hereunder (the “Exercise Price”).

 

c) Cashless Exercise. If at any time on or after the Initial Exercise Date, there is no effective registration statement registering the Warrant Shares, or the prospectus contained therein is not available for the issuance of the Warrant Shares to the Holder, then this Warrant may also be exercised, in whole or in part, at such time by means of a “cashless exercise” in which the Holder shall be entitled to receive a number of Warrant Shares equal to the quotient obtained by dividing [(A-B) (X)] by (A), where:

 

(A) = as applicable: (i) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of Exercise if such Notice of Exercise is (1) both executed and delivered pursuant to Section 2(a) hereof on a day that is not a Trading Day or (2) both executed and delivered pursuant to Section 2(a) hereof on a Trading Day prior to the opening of “regular trading hours” (as defined in Rule 600(b)(64) of Regulation NMS promulgated under the federal securities laws) on such Trading Day, (ii) the VWAP on the Trading Day immediately preceding the date of the applicable Notice of Exercise if such Notice of Exercise is executed during “regular trading hours” on a Trading Day and is delivered within two (2) hours thereafter (including until two (2) hours after the close of “regular trading hours” on a Trading Day) pursuant to Section 2(a) hereof or (iii) the VWAP on the date of the applicable Notice of Exercise if the date of such Notice of Exercise is a Trading Day and such Notice of Exercise is both executed and delivered pursuant to Section 2(a) hereof after the close of “regular trading hours” on such Trading Day;

 

(B) = the Exercise Price of this Warrant, as adjusted hereunder; and

 

(X) = the number of Warrant Shares that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means of a cash exercise rather than a cashless exercise.

 

If Warrant Shares are issued in such a “cashless exercise,” the parties acknowledge and agree that in accordance with Section 3(a)(9) of the Securities Act, the Warrant Shares shall take on the registered characteristics of the Warrants being exercised, and the holding period of the Warrants being exercised may be tacked on to the holding period of the Warrant Shares. The Company agrees not to take any position contrary to this Section 2(c).

 

Notwithstanding anything herein to the contrary, on the Termination Date, this Warrant shall be automatically exercised via cashless exercise pursuant to this Section 2(c).

 

 

1 125% of the public offering price per common share and warrant in the Offering.

 

 Ex. B-4  
 

 

d) Mechanics of Exercise.

 

i. Delivery of Warrant Shares Upon Exercise. The Company shall cause the Warrant Shares purchased hereunder to be transmitted by its transfer agent to the Holder by crediting the account of the Holder’s or its designee’s balance account with The Depository Trust Company through its Deposit or Withdrawal at Custodian system (the “DWAC”) if the Company is then a participant in such system and either (A) there is an effective registration statement permitting the issuance of the Warrant Shares to or resale of the Warrant Shares by Holder, or (B) the Warrant Shares are eligible for resale by the Holder without volume or manner-of-sale limitations pursuant to Rule 144 and, in either case, the Warrant Shares have been sold by the Holder prior to the Warrant Share Delivery Date (as defined below), and otherwise by physical delivery of a certificate, registered in the Company’s share register in the name of the Holder or its designee, for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise to the address specified by the Holder in the Notice of Exercise by the date that is the earlier of (i) two (2) Trading Days and (ii) the number of Trading Days comprising the Standard Settlement Period after the delivery to the Company of the Notice of Exercise (such date, the “Warrant Share Delivery Date”). If the Warrant Shares can be delivered via DWAC, the transfer agent shall have received from the Company, at the expense of the Company, any legal opinions or other documentation required by it to deliver such Warrant Shares without legend (subject to receipt by the Company of reasonable back up documentation from the Holder, including with respect to affiliate status) and, if applicable and requested by the Company prior to the Warrant Share Delivery Date, the transfer agent shall have received from the Holder a confirmation of sale of the Warrant Shares (provided the requirement of the Holder to provide a confirmation as to the sale of Warrant Shares shall not be applicable to the issuance of unlegended Warrant Shares upon a cashless exercise of this Warrant if the Warrant Shares are then eligible for resale pursuant to Rule 144(b)(1)). The Warrant Shares shall be deemed to have been issued, and Holder or any other person so designated to be named therein shall be deemed to have become a holder of record of such shares for all purposes, as of the date the Warrant has been exercised, with payment to the Company of the Exercise Price (or by cashless exercise, if permitted) and all taxes required to be paid by the Holder, if any, pursuant to Section 2(d)(vi) prior to the issuance of such shares, having been paid. If the Company fails for any reason to deliver to the Holder the Warrant Shares subject to a Notice of Exercise by the second Trading Day following the Warrant Share Delivery Date, the Company shall pay to the Holder, in cash, as liquidated damages and not as a penalty, for each $1,000 of Warrant Shares subject to such exercise (based on the VWAP of the Common Shares on the date of the applicable Notice of Exercise), $10 per Trading Day (increasing to $20 per Trading Day on the fifth Trading Day after such liquidated damages begin to accrue) for each Trading Day after the second Trading Day following such Warrant Share Delivery Date until such Warrant Shares are delivered or Holder rescinds such exercise.

 

ii. Delivery of New Warrants Upon Exercise. If this Warrant shall have been exercised in part, the Company shall, at the request of a Holder and upon surrender of this Warrant certificate, at the time of delivery of the Warrant Shares, deliver to the Holder a new Warrant evidencing the rights of the Holder to purchase the unpurchased Warrant Shares called for by this Warrant, which new Warrant shall in all other respects be identical with this Warrant.

 

iii. Rescission Rights. If the Company fails to cause its transfer agent to deliver to the Holder the Warrant Shares pursuant to Section 2(d)(i) by the Warrant Share Delivery Date, then the Holder will have the right to rescind such exercise; provided, however, that the Holder shall be required to return any Warrant Shares or Common Shares subject to any such rescinded exercise notice concurrently with the return to Holder of the aggregate Exercise Price paid to the Company for such Warrant Shares and the restoration of Holder’s right to acquire such Warrant Shares pursuant to this Warrant (including, issuance of a replacement warrant certificate evidencing such restored right).

 

 Ex. B-5  
 

 

iv. Compensation for Buy-In on Failure to Timely Deliver Warrant Shares Upon Exercise. In addition to any other rights available to the Holder, if the Company fails to cause its transfer agent to transmit to the Holder the Warrant Shares pursuant to an exercise on or before the Warrant Share Delivery Date, and if after such date the Holder is required by its broker to purchase (in an open market transaction or otherwise) or the Holder’s brokerage firm otherwise purchases, Common Shares to deliver in satisfaction of a sale by the Holder of the Warrant Shares which the Holder anticipated receiving upon such exercise (a “Buy-In”), then the Company shall (A) pay in cash to the Holder the amount, if any, by which (x) the Holder’s total purchase price (including brokerage commissions, if any) for the Common Shares so purchased exceeds (y) the amount obtained by multiplying (1) the number of Warrant Shares that the Company was required to deliver to the Holder in connection with the exercise at issue by (2) the price at which the sell order giving rise to such purchase obligation was executed, and (B) at the option of the Holder, either reinstate the portion of the Warrant and equivalent number of Warrant Shares for which such exercise was not honored (in which case such exercise shall be deemed rescinded) or deliver to the Holder the number of Common Shares that would have been issued had the Company timely complied with its exercise and delivery obligations hereunder. For example, if the Holder purchases Common Shares having a total purchase price of $11,000 to cover a Buy-In with respect to an attempted exercise of Common Shares with an aggregate sale price giving rise to such purchase obligation of $10,000, under clause (A) of the immediately preceding sentence the Company shall be required to pay the Holder $1,000. The Holder shall provide the Company written notice indicating the amounts payable to the Holder in respect of the Buy-In and, upon request of the Company, evidence of the amount of such loss. Nothing herein shall limit a Holder’s right to pursue any other remedies available to it hereunder, at law or in equity including, without limitation, a decree of specific performance and/or injunctive relief with respect to the Company’s failure to timely deliver Common Shares upon exercise of the Warrant as required pursuant to the terms hereof.

 

v. No Fractional Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant. As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall, at its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Exercise Price or round up to the next whole share.

 

vi. Charges, Taxes and Expenses. Issuance of Warrant Shares shall be made without charge to the Holder for any issue or transfer tax or other incidental expense in respect of the issuance of such Warrant Shares, all of which taxes and expenses shall be paid by the Company, and such Warrant Shares shall be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided, however, that in the event that Warrant Shares are to be issued in a name other than the name of the Holder, this Warrant when surrendered for exercise shall be accompanied by the Assignment Form attached hereto duly executed by the Holder and the Company may require, as a condition thereto, the payment of a sum sufficient to reimburse it for any transfer tax incidental thereto. The Company shall pay all transfer agent fees required for same-day processing of any Notice of Exercise and all fees to the Depository Trust Company (or another established clearing corporation performing similar functions) required for same-day electronic delivery of the Warrant Shares.

 

vii. Closing of Books. The Company shall not close its shareholder books or records in any manner which prevents the timely exercise of this Warrant, pursuant to the terms hereof.

 

viii. Signature. This Section 2 and the exercise form attached hereto set forth the totality of the procedures required of the Holder in order to exercise this Warrant. Without limiting the preceding sentences, no ink-original exercise form shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any exercise form be required in order to exercise this Warrant. No additional legal opinion, other information or instructions shall be required of the Holder to exercise this Warrant. The Company shall honor exercises of this Warrant and shall deliver Shares underlying this Warrant in accordance with the terms, conditions and time periods set forth herein.

 

 Ex. B-6  
 

 

e) Holder’s Exercise Limitations. The Company shall not effect any exercise of this Warrant, and a Holder shall not have the right to exercise any portion of this Warrant, pursuant to Section 2 or otherwise, to the extent that after giving effect to such issuance after exercise as set forth on the applicable Notice of Exercise, the Holder (together with the Holder’s Affiliates, and any other Persons acting as a group together with the Holder or any of the Holder’s Affiliates), would beneficially own in excess of the Beneficial Ownership Limitation (as defined below). For purposes of the foregoing sentence, the number of Common Shares beneficially owned by the Holder and its Affiliates shall include the number of Common Shares issuable upon exercise of this Warrant with respect to which such determination is being made, but shall exclude the number of Common Shares which would be issuable upon (i) exercise of the remaining, nonexercised portion of this Warrant beneficially owned by the Holder or any of its Affiliates and (ii) exercise or conversion of the unexercised or nonconverted portion of any other securities of the Company (including, without limitation, any other Common Share Equivalents) subject to a limitation on conversion or exercise analogous to the limitation contained herein beneficially owned by the Holder or any of its Affiliates. Except as set forth in the preceding sentence, for purposes of this Section 2(e), beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder, it being acknowledged by the Holder that the Company is not representing to the Holder that such calculation is in compliance with Section 13(d) of the Exchange Act and the Holder is solely responsible for any schedules required to be filed in accordance therewith. To the extent that the limitation contained in this Section 2(e) applies, the determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates) and of which portion of this Warrant is exercisable shall be in the sole discretion of the Holder, and the submission of a Notice of Exercise shall be deemed to be the Holder’s determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates) and of which portion of this Warrant is exercisable, in each case subject to the Beneficial Ownership Limitation, and the Company shall have no obligation to verify or confirm the accuracy of such determination. In addition, a determination as to any group status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder. For purposes of this Section 2(e), in determining the number of outstanding Common Shares, a Holder may rely on the number of outstanding Common Shares as reflected in (A) the Company’s most recent periodic or annual report filed with the Commission, as the case may be, (B) a more recent public announcement by the Company or (C) a more recent written notice by the Company or the Company’s transfer agent setting forth the number of Common Shares outstanding. Upon the written or oral request of a Holder, the Company shall within two Trading Days confirm orally and in writing to the Holder the number of Common Shares then outstanding. In any case, the number of outstanding Common Shares shall be determined after giving effect to the conversion or exercise of securities of the Company, including this Warrant, by the Holder or its Affiliates since the date as of which such number of outstanding Common Shares was reported. The “Beneficial Ownership Limitation” shall be 9.99% of the number of Common Shares outstanding immediately after giving effect to the issuance of Common Shares issuable upon exercise of this Warrant. The Holder, upon notice to the Company, may increase or decrease the Beneficial Ownership Limitation provisions of this Section 2(e), provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of Common Shares outstanding immediately after giving effect to the issuance of Common Shares upon exercise of this Warrant held by the Holder and the provisions of this Section 2(e) shall continue to apply. Any increase in the Beneficial Ownership Limitation will not be effective until the 61st day after such notice is delivered to the Company. The provisions of this paragraph shall be construed and implemented in a manner otherwise than in strict conformity with the terms of this Section 2(e) to correct this paragraph (or any portion hereof) which may be defective or inconsistent with the intended Beneficial Ownership Limitation herein contained or to make changes or supplements necessary or desirable to properly give effect to such limitation. The limitations contained in this paragraph shall apply to a successor holder of this Warrant.

 

 Ex. B-7  
 

 

Section 3. Certain Adjustments.

 

a) Stock Dividends and Splits. If the Company, at any time while this Warrant is outstanding: (i) pays a stock dividend or otherwise makes a distribution or distributions on Common Shares or any other equity or equity equivalent securities payable in Common Shares (which, for avoidance of doubt, shall not include any Common Shares issued by the Company upon exercise of this Warrant), (ii) subdivides outstanding Common Shares into a larger number of shares, (iii) combines (including by way of reverse share split or consolidation) outstanding Common Shares into a smaller number of shares, or (iv) issues by reclassification of Common Shares any shares of capital stock of the Company, then in each case the Exercise Price shall be multiplied by a fraction of which the numerator shall be the number of Common Shares (excluding treasury shares, if any) outstanding immediately before such event and of which the denominator shall be the number of Common Shares outstanding immediately after such event, and the number of shares issuable upon exercise of this Warrant shall be proportionately adjusted such that the aggregate Exercise Price of this Warrant shall remain unchanged. Any adjustment made pursuant to this Section 3(a) shall become effective immediately after the record date for the determination of shareholders entitled to receive such dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or re-classification. For the purposes of clarification, the Exercise Price of this Warrant will not be adjusted in the event that the Company or any subsidiary thereof, as applicable, sells or grants any option to purchase, or sell or grant any right to reprice, or otherwise dispose of or issue (or announce any offer, sale, grant or any option to purchase or other disposition) any Common Shares or Common Share Equivalents, at an effective price per share less than the Exercise Price then in effect.

 

b) [RESERVED]

 

c) Subsequent Rights Offerings. In addition to any adjustments pursuant to Section 3(a) above, if at any time the Company grants, issues or sells any Common Share Equivalents or rights to purchase shares, warrants, securities or other property pro rata to all or substantially all of the record holders of Common Shares (the “Purchase Rights”), then the Holder will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the Holder could have acquired if the Holder had held the number of Common Shares acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date on which a record is taken for the grant, issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record holders of Common Shares are to be determined for the grant, issue or sale of such Purchase Rights (provided, however, to the extent that the Holder’s right to participate in any such Purchase Right would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Purchase Right to such extent (or beneficial ownership of such Common Shares as a result of such Purchase Right to such extent) and such Purchase Right to such extent shall be held in abeyance for the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation).

 

 Ex. B-8  
 

 

d) Pro Rata Distributions. During such time as this Warrant is outstanding, if the Company shall declare or make any dividend or other distribution of its assets (or rights to acquire its assets) to holders of Common Shares, by way of return of capital or otherwise (including, without limitation, any distribution of cash, shares or other securities, property or options by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar transaction) (a “Distribution”), at any time after the issuance of this Warrant, then, in each such case, the Holder shall be entitled to participate in such Distribution to the same extent that the Holder would have participated therein if the Holder had held the number of Common Shares acquirable upon complete exercise of this Warrant (without regard to any limitations on exercise hereof, including without limitation, the Beneficial Ownership Limitation) immediately before the date of which a record is taken for such Distribution, or, if no such record is taken, the date as of which the record holders of Common Shares are to be determined for the participation in such Distribution (provided, however, to the extent that the Holder’s right to participate in any such Distribution would result in the Holder exceeding the Beneficial Ownership Limitation, then the Holder shall not be entitled to participate in such Distribution to such extent (or in the beneficial ownership of any Common Shares as a result of such Distribution to such extent) and the portion of such Distribution shall be held in abeyance for the benefit of the Holder until such time, if ever, as its right thereto would not result in the Holder exceeding the Beneficial Ownership Limitation). To the extent that this Warrant has not been partially or completely exercised at the time of such Distribution, such portion of the Distribution shall be held in abeyance for the benefit of the Holder until the Holder has exercised this Warrant.

 

e) Fundamental Transaction. If, at any time while this Warrant is outstanding, (i) the Company, directly or indirectly, in one or more related transactions effects any merger, amalgamation, arrangement or consolidation of the Company with or into another Person, (ii) the Company, directly or indirectly, effects any sale, lease, license, assignment, transfer, conveyance or other disposition of all or substantially all of its assets in one or a series of related transactions, (iii) any, direct or indirect, purchase offer, tender offer or exchange offer (whether by the Company or another Person) is completed pursuant to which holders of Common Shares are permitted to sell, tender or exchange their shares for other securities, cash or property and has been accepted by the holders of 50% or more of the outstanding Common Shares, (iv) the Company, directly or indirectly, in one or more related transactions effects any reclassification, reorganization or recapitalization of the Common Shares or any compulsory share exchange pursuant to which the Common Shares are effectively converted into or exchanged for other securities, cash or property, or (v) the Company, directly or indirectly, in one or more related transactions consummates a share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off or scheme of arrangement) with another Person or group of Persons whereby such other Person or group acquires more than 50% of the outstanding Common Shares (not including any Common Shares held by the other Person or other Persons making or party to, or associated or affiliated with the other Persons making or party to, such share purchase agreement or other business combination) (each a “Fundamental Transaction”), then, upon any subsequent exercise of this Warrant, the Holder shall have the right to receive, for each Warrant Share that would have been issuable upon such exercise immediately prior to the occurrence of such Fundamental Transaction, at the option of the Holder (without regard to any limitation in Section 2(e) on the exercise of this Warrant), the number of Common Shares of the successor or acquiring corporation or of the Company, if it is the surviving corporation or is otherwise the continuing corporation, and any additional consideration (the “Alternate Consideration”) receivable by holders of Common Shares as a result of such Fundamental Transaction for each Common Share for which this Warrant is exercisable immediately prior to such Fundamental Transaction (without regard to any limitation in Section 2(e) on the exercise of this Warrant). For purposes of any such exercise, the determination of the Exercise Price shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one Common Share in such Fundamental Transaction, and the Company shall apportion the Exercise Price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of Common Shares are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holder shall be given the same choice as to the Alternate Consideration it receives upon any exercise of this Warrant following such Fundamental Transaction. The Company shall cause any successor entity in a Fundamental Transaction in which the Company is not the survivor (the “Successor Entity”) to assume in writing all of the obligations of the Company under this Warrant in accordance with the provisions of this Section 3(e) pursuant to written agreements in form and substance reasonably satisfactory to the Holder and approved by the Holder (without unreasonable delay) prior to such Fundamental Transaction and shall, at the option of the Holder, deliver to the Holder in exchange for this Warrant a security of the Successor Entity evidenced by a written instrument substantially similar in form and substance to this Warrant which is exercisable for a corresponding number of shares or other securities of such Successor Entity (or its parent entity) equivalent to the Common Shares acquirable and receivable upon exercise of this Warrant (without regard to any limitations on the exercise of this Warrant) prior to such Fundamental Transaction, and with an exercise price which applies the exercise price hereunder to such shares or other securities (but taking into account the relative value of the Common Shares pursuant to such Fundamental Transaction and the value of such shares or other securities, such number of shares or other securities and such exercise price being for the purpose of protecting the economic value of this Warrant immediately prior to the consummation of such Fundamental Transaction), and which is reasonably satisfactory in form and substance to the Holder. Upon the occurrence of any such Fundamental Transaction, the Successor Entity shall succeed to, and be substituted for (so that from and after the date of such Fundamental Transaction, the provisions of this Warrant referring to the “Company” shall refer instead to the Successor Entity), and may exercise every right and power of the Company and shall assume all of the obligations of the Company under this Warrant with the same effect as if such Successor Entity had been named as the Company herein.

 

 Ex. B-9  
 

 

f) Calculations. All calculations under this Section 3 shall be made to the nearest cent or the nearest 1/100th of a share, as the case may be. For purposes of this Section 3, the number of Common Shares deemed to be issued and outstanding as of a given date shall be the sum of the number of Common Shares (excluding treasury shares, if any) issued and outstanding.

 

g) Notice to Holder.

 

i. Adjustment to Exercise Price. Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3, the Company shall promptly mail to the Holder a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts requiring such adjustment.

 

ii. Notice to Allow Exercise by Holder. If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Common Shares, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Common Shares, (C) the Company shall authorize the granting to all holders of the Common Shares rights or warrants to subscribe for or purchase any shares of the Company or of any rights, (D) the approval of any shareholders of the Company shall be required in connection with any reclassification of the Common Shares, any consolidation, merger, amalgamation or arrangement to which the Company is a party, any sale or transfer of all or substantially all of the assets of the Company, or any compulsory share exchange whereby the Common Shares are converted into other securities, cash or property, or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, then, in each case, the Company shall cause to be mailed a notice to the Holder at its last address as it shall appear upon the Warrant Register of the Company, at least 20 calendar days prior to the applicable record or effective date hereinafter specified, stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Common Shares of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, amalgamation, arrangement, sale, transfer or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Common Shares of record shall be entitled to exchange their Common Shares for securities, cash or other property deliverable upon such reclassification, consolidation, merger, amalgamation, arrangement, sale, transfer or share exchange; provided that the failure to provide such notice or any defect therein shall not affect the validity of the corporate action required to be specified in such notice. To the extent that any notice provided hereunder constitutes, or contains, material, non-public information regarding the Company or any of its subsidiaries, the Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form 8-K or a Report of Foreign Private Issuer on Form 6-K. The Holder shall remain entitled to exercise this Warrant during the period commencing on the date of such notice to the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.

 

Section 4. Transfer of Warrant.

 

a) Transferability. Pursuant to FINRA Rule 5110(g)(1), neither this Warrant nor any Warrant Shares issued upon exercise of this Warrant shall be sold, transferred, assigned, pledged, or hypothecated, or be the subject of any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the securities by any person for a period of 180 days immediately following the date of effectiveness or commencement of sales of the Offering, except the transfer of any security:

 

i. by operation of law or by reason of reorganization of the Company;

 

ii. to any FINRA member firm participating in the Offering and the officers or partners thereof, if all securities so transferred remain subject to the lock-up restriction in this Section 4(a) for the remainder of the time period;

 

iii. if the aggregate amount of securities of the Company held by the Holder or related person do not exceed 1% of the securities being offered;

 

iv. that is beneficially owned on a pro-rata basis by all equity owners of an investment fund, provided that no participating member manages or otherwise directs investments by the fund, and participating members in the aggregate do not own more than 10% of the equity in the fund; or

 

v. the exercise or conversion of any security, if all securities received remain subject to the lock-up restriction in this Section 4(a) for the remainder of the time period.

 

 Ex. B-10  
 

 

Subject to the foregoing restriction, any applicable securities laws and the conditions set forth in Section 4(d), this Warrant and all rights hereunder (including, without limitation, any registration rights) are transferable, in whole or in part, upon surrender of this Warrant at the principal office of the Company or its designated agent, together with a written assignment of this Warrant substantially in the form attached hereto duly executed by the Holder or its agent or attorney and funds sufficient to pay any transfer taxes payable upon the making of such transfer. Upon such surrender and, if required, such payment, the Company shall execute and deliver a new Warrant or Warrants in the name of the assignee or assignees, as applicable, and in the denomination or denominations specified in such instrument of assignment, and shall issue to the assignor a new Warrant evidencing the portion of this Warrant not so assigned, and this Warrant shall promptly be cancelled. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company unless the Holder has assigned this Warrant in full, in which case, the Holder shall surrender this Warrant to the Company within three (3) Trading Days of the date the Holder delivers an assignment form to the Company assigning this Warrant full. The Warrant, if properly assigned in accordance herewith, may be exercised by a new holder for the purchase of Warrant Shares without having a new Warrant issued.

 

Notwithstanding the foregoing, so long as the Common Shares are listed on the TSX Venture Exchange (the “TSXV”), this Warrant may not be sold, transferred, assigned, pledged, or hypothecated, or be the subject of any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the securities, to any person other than an affiliate or employee (or an affiliate of such employee) of [NAME OF UNDERWRITER] within the meaning of the policies of the TSXV or any other FINRA member firm participating in the Offering as an underwriter or selected dealer and the officers and partners thereof.

 

b) New Warrants. This Warrant may be divided or combined with other Warrants upon presentation hereof at the aforesaid office of the Company, together with a written notice specifying the names and denominations in which new Warrants are to be issued, signed by the Holder or its agent or attorney. Subject to compliance with Section 4(a), as to any transfer which may be involved in such division or combination, the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or Warrants to be divided or combined in accordance with such notice. All Warrants issued on transfers or exchanges shall be dated the initial issuance date of this Warrant and shall be identical with this Warrant except as to the number of Warrant Shares issuable pursuant thereto.

 

c) Warrant Register. The Company shall register this Warrant, upon records to be maintained by the Company for that purpose (the “Warrant Register”), in the name of the record Holder hereof from time to time. The Company may deem and treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary.

 

d) Representation by the Holder. The Holder, by the acceptance hereof, represents and warrants that it is acquiring this Warrant and, upon any exercise hereof, will acquire the Warrant Shares issuable upon such exercise, for its own account and not with a view to or for distributing or reselling such Warrant Shares or any part thereof in violation of the Securities Act or any applicable state securities law, except pursuant to sales registered or exempted under the Securities Act.

 

 Ex. B-11  
 

 

Section 5. Registration Rights.

 

a) Demand Registration.

 

i. Grant of Right. The Company, upon written demand (a “Demand Notice”) of the Holder(s) of at least 51% of the Warrants and/or the underlying Warrant Shares (the “Majority Holders”), agrees to register, on one occasion, all or any portion of the Warrant Shares underlying the Warrants (collectively, the “Registrable Securities”). On such occasion, the Company shall file a registration statement with the Commission covering the Registrable Securities within sixty (60) days after receipt of a Demand Notice and use its reasonable best efforts to have the registration statement declared effective promptly thereafter, subject to compliance with review by the Commission; provided, however, that the Company shall not be required to comply with a Demand Notice if the Company has filed a registration statement with respect to which the Holder is entitled to piggyback registration rights pursuant to Section 5(b) hereof and either: (i) the Holder has elected to participate in the offering covered by such registration statement or (ii) if such registration statement relates to an underwritten primary offering of securities of the Company, until the offering covered by such registration statement has been withdrawn or until thirty (30) days after such offering is consummated. The demand for registration may be made at any time beginning on the Initial Exercise Date and expiring on the fifth anniversary of the Effective Date. The Company covenants and agrees to give written notice of its receipt of any Demand Notice by any Holder(s) to all other registered Holders of the Warrants and/or the Registrable Securities within ten (10) days after the date of the receipt of any such Demand Notice.

 

ii. Terms. The Company shall bear all fees and expenses attendant to the registration of the Registrable Securities pursuant to Section 5(a)(i), but the Holders shall pay any and all underwriting commissions and the expenses of any legal counsel selected by the Holders to represent them in connection with the sale of the Registrable Securities. The Company agrees to use its reasonable best efforts to cause the filing required herein to become effective promptly and to qualify or register the Registrable Securities in such States as are reasonably requested by the Holder(s); provided, however, that in no event shall the Company be required to register the Registrable Securities in a State in which such registration would cause: (i) the Company to be obligated to register or license to do business in such State or submit to general service of process in such State, or (ii) the principal shareholders of the Company to be obligated to escrow their shares of capital stock of the Company. The Company shall cause any registration statement filed pursuant to the demand right granted under Section 5(a)(i) to remain effective for a period of at least twelve (12) consecutive months after the date that the Holders of the Registrable Securities covered by such registration statement are first given the opportunity to sell all of such securities. The Holders shall only use the prospectuses provided by the Company to sell the Warrant Shares covered by such registration statement, and will immediately cease to use any prospectus furnished by the Company if the Company advises the Holder that such prospectus may no longer be used due to a material misstatement or omission. Notwithstanding the provisions of this Section 5(a)(ii), the Holder shall be entitled to a demand registration under this Section 5(a)(ii) on only one (1) occasion and such demand registration right shall terminate on the fifth anniversary of the date of the Underwriting Agreement (as defined below) in accordance with FINRA Rule 5110(f)(2)(G)(iv).

 

b) “Piggy-Back” Registration.

 

i. Grant of Right. In addition to the demand right of registration described in Section 5(a) hereof, the Holder shall have the right, for a period of no more than two (2) years from the Initial Exercise Date in accordance with FINRA Rule 5110(f)(2)(G)(v), to include the Registrable Securities as part of any other registration of securities filed by the Company (other than in connection with a transaction contemplated by Rule 145(a) promulgated under the Securities Act or pursuant to Form S-8 or any equivalent form); provided, however, that if, solely in connection with any primary underwritten public offering for the account of the Company, the managing underwriter(s) thereof shall, in its reasonable discretion, impose a limitation on the number of Registrable Securities which may be included in the Registration Statement because, in such underwriter(s)’ judgment, marketing or other factors dictate such limitation is necessary to facilitate public distribution, then the Company shall be obligated to include in such Registration Statement only such limited portion of the Registrable Securities with respect to which the Holder requested inclusion hereunder as the underwriter shall reasonably permit. Any exclusion of Registrable Securities shall be made pro rata among the Holders seeking to include Registrable Securities in proportion to the number of Registrable Securities sought to be included by such Holders; provided, however, that the Company shall not exclude any Registrable Securities unless the Company has first excluded all outstanding securities, the holders of which are not entitled to inclusion of such securities in such Registration Statement or are not entitled to pro rata inclusion with the Registrable Securities.

 

 Ex. B-12  
 

 

ii. Terms. The Company shall bear all fees and expenses attendant to registering the Registrable Securities pursuant to Section 5(b)(i) hereof, but the Holders shall pay any and all underwriting commissions and the expenses of any legal counsel selected by the Holders to represent them in connection with the sale of the Registrable Securities. In the event of such a proposed registration, the Company shall furnish the then Holders of outstanding Registrable Securities with not less than thirty (30) days written notice prior to the proposed date of filing of such registration statement. Such notice to the Holders shall continue to be given for each registration statement filed by the Company during the two (2) year period following the Initial Exercise Date until such time as all of the Registrable Securities have been sold by the Holder. The holders of the Registrable Securities shall exercise the “piggy-back” rights provided for herein by giving written notice within ten (10) days of the receipt of the Company’s notice of its intention to file a registration statement. Except as otherwise provided in this Warrant, there shall be no limit on the number of times the Holder may request registration under this Section 5(b)(ii); provided, however, that such registration rights shall terminate on the second anniversary of the Initial Exercise Date.

 

c) General Terms

 

i. Indemnification. The Company shall indemnify the Holder(s) of the Registrable Securities to be sold pursuant to any registration statement hereunder and each person, if any, who controls such Holders within the meaning of Section 15 of the Securities Act or Section 20 (a) of the Exchange Act against all loss, claim, damage, expense or liability (including all reasonable attorneys’ fees and other expenses reasonably incurred in investigating, preparing or defending against any claim whatsoever) to which any of them may become subject under the Securities Act, the Exchange Act or otherwise, arising from such registration statement but only to the same extent and with the same effect as the provisions pursuant to which the Company has agreed to indemnify the Underwriters contained in Section 5.1 of the Underwriting Agreement between the Underwriters and the Company, dated as of [___], 2020. The Holder(s) of the Registrable Securities to be sold pursuant to such registration statement, and their successors and assigns, shall severally, and not jointly, indemnify the Company, against all loss, claim, damage, expense or liability (including all reasonable attorneys’ fees and other expenses reasonably incurred in investigating, preparing or defending against any claim whatsoever) to which they may become subject under the Securities Act, the Exchange Act or otherwise, arising from information furnished by or on behalf of such Holders, or their successors or assigns, in writing, for specific inclusion in such registration statement to the same extent and with the same effect as the provisions contained in Section 5.2 of the Underwriting Agreement pursuant to which the Underwriters have agreed to indemnify the Company.

 

ii. Exercise of Warrants. Nothing contained in this Warrant shall be construed as requiring the Holder(s) to exercise their Warrants prior to or after the initial filing of any registration statement or the effectiveness thereof.

 

 Ex. B-13  
 

 

iii. Documents Delivered to Holders. The Company shall furnish to each Holder participating in any of the foregoing offerings and to each underwriter of any such offering, if any, a signed counterpart, addressed to such Holder or underwriter, of: (i) an opinion of counsel to the Company, dated the effective date of such registration statement (and, if such registration includes an underwritten public offering, an opinion dated the date of the closing under any underwriting agreement related thereto), and (ii) a “cold comfort” letter dated the effective date of such registration statement (and, if such registration includes an underwritten public offering, a letter dated the date of the closing under the underwriting agreement) signed by the independent registered public accounting firm which has issued a report on the Company’s financial statements included in such registration statement, in each case covering substantially the same matters with respect to such registration statement (and the prospectus included therein) and, in the case of such accountants’ letter, with respect to events subsequent to the date of such financial statements, as are customarily covered in opinions of issuer’s counsel and in accountants’ letters delivered to underwriters in underwritten public offerings of securities. The Company shall also deliver promptly to each Holder participating in the offering requesting the correspondence and memoranda described below and to the managing underwriter, if any, copies of all correspondence between the Commission and the Company, its counsel or auditors and all memoranda relating to discussions with the Commission or its staff with respect to the registration statement and permit each Holder and underwriter to do such investigation, upon reasonable advance notice, with respect to information contained in or omitted from the registration statement as it deems reasonably necessary to comply with applicable securities laws or rules of FINRA. Such investigation shall include access to books, records and properties and opportunities to discuss the business of the Company with its officers and independent auditors, all to such reasonable extent and at such reasonable times as any such Holder shall reasonably request.

 

iv. Underwriting Agreement. The Company shall enter into an underwriting agreement with the managing underwriter(s), if any, selected by any Holders whose Registrable Securities are being registered pursuant to this Section 5, which managing underwriter shall be reasonably satisfactory to the Company. Such agreement shall be reasonably satisfactory in form and substance to the Company, each Holder and such managing underwriters, and shall contain such representations, warranties and covenants by the Company and such other terms as are customarily contained in agreements of that type used by the managing underwriter. The Holders shall be parties to any underwriting agreement relating to an underwritten sale of their Registrable Securities and may, at their option, require that any or all the representations, warranties and covenants of the Company to or for the benefit of such underwriters shall also be made to and for the benefit of such Holders. Such Holders shall not be required to make any representations or warranties to or agreements with the Company or the underwriters except as they may relate to such Holders, their Warrant Shares and their intended methods of distribution.

 

v. Documents to be Delivered by Holder(s). Each of the Holder(s) participating in any of the foregoing offerings shall furnish to the Company a completed and executed questionnaire provided by the Company requesting information customarily sought of selling security holders.

 

vi. Damages. Should the registration or the effectiveness thereof required by Sections 5(a) and 5(b) hereof be delayed by the Company or the Company otherwise fails to comply with such provisions, the Holder(s) shall, in addition to any other legal or other relief available to the Holder(s), be entitled to obtain specific performance or other equitable (including injunctive) relief against the threatened breach of such provisions or the continuation of any such breach, without the necessity of proving actual damages and without the necessity of posting bond or other security.

 

 Ex. B-14  
 

 

Section 6. Miscellaneous.

 

a) No Rights as Shareholder Until Exercise. This Warrant does not entitle the Holder to any voting rights, dividends or other rights as a shareholder of the Company prior to the exercise hereof as set forth in Section 2(d)(i).

 

b) Loss, Theft, Destruction or Mutilation of Warrant. The Company covenants that upon receipt by the Company of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any certificate relating to the Warrant Shares, and in case of loss, theft or destruction, of indemnity or security reasonably satisfactory to it (which shall in no event include the posting of any bond), and upon surrender and cancellation of such Warrant or share certificate, if mutilated, the Company shall make and deliver a new Warrant or share certificate of like tenor and dated as of such cancellation, in lieu of such Warrant or share certificate.

 

c) Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Trading Day, then, such action may be taken or such right may be exercised on the next succeeding Trading Day.

 

d) Authorized Shares.

 

The Company covenants that, during the period the Warrant is outstanding, it will reserve from its authorized and unissued Common Shares a sufficient number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant. The Company further covenants that its issuance of this Warrant shall constitute full authority to its officers who are charged with the duty of issuing the necessary Warrant Shares upon the exercise of the purchase rights under this Warrant. The Company shall take all such reasonable action as may be necessary to assure that such Warrant Shares may be issued as provided herein without violation of any applicable law or regulation, or of any requirements of the Trading Market upon which the Common Shares may be listed. The Company covenants that all Warrant Shares which may be issued upon the exercise of the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for such Warrant Shares in accordance herewith, be duly authorized, validly issued, fully paid and non-assessable and free from all taxes, liens and charges created by the Company in respect of the issue thereof (other than taxes in respect of any transfer occurring contemporaneously with such issue).

 

Except and to the extent as waived or consented to by the Holder, the Company shall not by any action, including, without limitation, amending its certificate of incorporation or through any reorganization, transfer of assets, consolidation, merger, amalgamation, arrangement, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate to protect the rights of Holder as set forth in this Warrant against impairment. Without limiting the generality of the foregoing, the Company shall (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise immediately prior to such increase in par value, (ii) take all such action as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and non-assessable Warrant Shares upon the exercise of this Warrant and (iii) use commercially reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof, as may be, necessary to enable the Company to perform its obligations under this Warrant.

 

 Ex. B-15  
 

 

Before taking any action which would result in an adjustment in the number of Warrant Shares for which this Warrant is exercisable or in the Exercise Price, the Company shall obtain all such authorizations or exemptions thereof, or consents thereto, as may be necessary from any public regulatory body or bodies having jurisdiction thereof.

 

e) Jurisdiction. All questions concerning the construction, validity, enforcement and interpretation of this Warrant shall be determined in accordance with the provisions of the underwriting agreement, dated _______________, 20___, by and between the Company and ThinkEquity, a division of Fordham Financial Management, Inc., as representatives of the underwriters set forth therein (the “Underwriting Agreement”).

 

f) Restrictions. The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant, if not registered, and the Holder does not utilize cashless exercise, will have restrictions upon resale imposed by state and federal securities laws.

 

g) Nonwaiver and Expenses. No course of dealing or any delay or failure to exercise any right hereunder on the part of Holder shall operate as a waiver of such right or otherwise prejudice the Holder’s rights, powers or remedies. Without limiting any other provision of this Warrant or the Underwriting Agreement, if the Company willfully and knowingly fails to comply with any provision of this Warrant, which results in any material damages to the Holder, the Company shall pay to the Holder such amounts as shall be sufficient to cover any costs and expenses including, but not limited to, reasonable attorneys’ fees, including those of appellate proceedings, incurred by the Holder in collecting any amounts due pursuant hereto or in otherwise enforcing any of its rights, powers or remedies hereunder.

 

h) Notices. Any notice, request or other document required or permitted to be given or delivered to the Holder by the Company shall be delivered in accordance with the notice provisions of the Underwriting Agreement.

 

i) Limitation of Liability. No provision hereof, in the absence of any affirmative action by the Holder to exercise this Warrant to purchase Warrant Shares, and no enumeration herein of the rights or privileges of the Holder, shall give rise to any liability of the Holder for the purchase price of any Common Shares or as a shareholder of the Company, whether such liability is asserted by the Company or by creditors of the Company.

 

j) Remedies. The Holder, in addition to being entitled to exercise all rights granted by law, including recovery of damages, will be entitled to specific performance of its rights under this Warrant. The Company agrees that monetary damages would not be adequate compensation for any loss incurred by reason of a breach by it of the provisions of this Warrant and hereby agrees to waive and not to assert the defense in any action for specific performance that a remedy at law would be adequate.

 

k) Successors and Assigns. Subject to applicable securities laws, this Warrant and the rights and obligations evidenced hereby shall inure to the benefit of and be binding upon the successors and permitted assigns of the Company and the successors and permitted assigns of Holder. The provisions of this Warrant are intended to be for the benefit of any Holder from time to time of this Warrant and shall be enforceable by the Holder or holder of Warrant Shares.

 

l) Amendment. This Warrant may be modified or amended or the provisions hereof waived with the written consent of the Company and the Holder.

 

m) Severability. Wherever possible, each provision of this Warrant shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Warrant shall be prohibited by or invalid under applicable law, such provision shall be ineffective to the extent of such prohibition or invalidity, without invalidating the remainder of such provisions or the remaining provisions of this Warrant.

 

n) Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose, be deemed a part of this Warrant.

 

********************

 

(Signature Page Follows)

 

 Ex. B-16  
 

 

IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its officer thereunto duly authorized as of the date first above indicated.

 

  BRIACELL THERAPEUTICS CORP.
                          
  By:  
  Name:  
  Title:  

 

 Ex. B-17  
 

 

NOTICE OF EXERCISE

 

TO: BRIACELL THERAPEUTICS CORP.

 

_________________________

 

(1) The undersigned hereby elects to purchase ________ Warrant Shares of the Company pursuant to the terms of the attached Warrant (only if exercised in full), and tenders herewith payment of the exercise price in full, together with all applicable transfer taxes, if any.

 

(2) Payment shall take the form of (check applicable box):

 

  [  ] in lawful money of the United States; or
     
  [  ] if permitted the cancellation of such number of Warrant Shares as is necessary, in accordance with the formula set forth in subsection 2(c), to exercise this Warrant with respect to the maximum number of Warrant Shares purchasable pursuant to the cashless exercise procedure set forth in subsection 2(c).

 

(3) Please register and issue said Warrant Shares in the name of the undersigned or in such other name as is specified below:

 

_______________________________

 

The Warrant Shares shall be delivered to the following DWAC Account Number or by physical delivery of a certificate to:

 

_______________________________

 

_______________________________

 

_______________________________

 

(4) Accredited Investor. If the Warrant is being exercised via cash exercise, the undersigned is an “accredited investor” as defined in Regulation D promulgated under the Securities Act of 1933, as amended

 

 Ex. B-18  
 

 

[SIGNATURE OF HOLDER]

 

Name of Investing Entity: ___________________________________________________________________________

 

Signature of Authorized Signatory of Investing Entity: _____________________________________________________

 

Name of Authorized Signatory: _______________________________________________________________________

 

Title of Authorized Signatory: ________________________________________________________________________

 

Date: ___________________________________________________________________________________________

 

 Ex. B-19  
 

 

ASSIGNMENT FORM

 

(To assign the foregoing warrant, execute this form and supply required information.
Do not use this form to exercise the warrant.)

 

FOR VALUE RECEIVED, [____] all of or [_______] shares of the foregoing Warrant and all rights evidenced thereby are hereby assigned to

 

_______________________________________________ whose address is

 

_______________________________________________________________.

 

_______________________________________________________________

 

Dated: ______________, _______

 

Holder’s Signature: _____________________________

 

Holder’s Address: _____________________________

 

_____________________________

 

NOTE: The signature to this Assignment Form must correspond with the name as it appears on the face of the Warrant, without alteration or enlargement or any change whatsoever. Officers of corporations and those acting in a fiduciary or other representative capacity should file proper evidence of authority to assign the foregoing Warrant.

 

 Ex. B-20  
 

 

Exhibit C

 

Lock-Up Agreement

 

______________, 20___

 

ThinkEquity
A Division of Fordham Financial Management, Inc.

17 State Street, 22nd Floor

New York, NY 10004

 

As Representative of the several Underwriters named on Schedule 1 to the Underwriting Agreement referenced below

 

Ladies and Gentlemen:

 

The undersigned understands that ThinkEquity, a Division of Fordham Financial Management, Inc. (the “Representative”), proposes to enter into an Underwriting Agreement (the “Underwriting Agreement”) with BriaCell Therapeutics Corp., a British Columbia corporation (the “Company”), providing for the public offering (the “Public Offering”) of units of the Company comprised of (a) (i) one common share of the Company, without par value per share, (each, a “Common Share”) or (ii) one pre-funded warrant to purchase one Common Share and (b) one warrant to purchase one Common Share.

 

To induce the Representative to continue its efforts in connection with the Public Offering, the undersigned hereby agrees that, without the prior written consent of the Representative, the undersigned will not, during the period commencing on the date hereof and ending six months after the date of the Underwriting Agreement relating to the Public Offering (the “Lock-Up Period”), (1) offer, pledge, sell, contract to sell, grant, lend, or otherwise transfer or dispose of, directly or indirectly, any Common Shares or any securities convertible into or exercisable or exchangeable for Common Shares, whether now owned or hereafter acquired by the undersigned or with respect to which the undersigned has or hereafter acquires the power of disposition (collectively, the “Lock-Up Securities”); (2) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the Lock-Up Securities, whether any such transaction described in clause (1) or (2) above is to be settled by delivery of Lock-Up Securities, in cash or otherwise; (3) make any demand for or exercise any right with respect to the registration of any Lock-Up Securities; or (4) publicly disclose the intention to make any offer, sale, pledge or disposition, or to enter into any transaction, swap, hedge or other arrangement relating to any Lock-Up Securities. Notwithstanding the foregoing, and subject to the conditions below, the undersigned may transfer Lock-Up Securities without the prior written consent of the Representative in connection with (a) transactions relating to Lock-Up Securities acquired in open market transactions after the completion of the Public Offering; provided that no filing under Section 13 or Section 16(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or other public announcement shall be required or shall be voluntarily made in connection with subsequent sales of Lock-Up Securities acquired in such open market transactions; (b) transfers of Lock-Up Securities as a bona fide gift, by will or intestacy or to a family member or trust for the benefit of the undersigned or a family member (for purposes of this lock-up agreement, “family member” means any relationship by blood, marriage or adoption, not more remote than first cousin); (c) transfers of Lock-Up Securities to a charity or educational institution; (d) if the undersigned is a corporation, partnership, limited liability company or other business entity, (i) any transfers of Lock-Up Securities to another corporation, partnership or other business entity that controls, is controlled by or is under common control with the undersigned or (ii) distributions of Lock-Up Securities to members, partners, shareholders, subsidiaries or affiliates (as defined in Rule 405 promulgated under the Securities Act of 1933, as amended) of the undersigned; (e) if the undersigned is a trust, to a trustee or beneficiary of the trust; provided that in the case of any transfer pursuant to the foregoing clauses (b), (c) (d) or (e), (i) any such transfer shall not involve a disposition for value, (ii) each transferee shall sign and deliver to the Representative a lock-up agreement substantially in the form of this lock-up agreement and (iii) no filing under Section 13 or Section 16(a) of the Exchange Act or other public announcement shall be required or shall be voluntarily made; (f) the receipt by the undersigned from the Company of Common Shares upon the vesting of restricted stock awards or stock units or upon the exercise of options to purchase the Company’s Common Shares issued under an equity incentive plan of the Company or an employment arrangement described in the Pricing Prospectus (as defined in the Underwriting Agreement) (the “Plan Shares”) or the transfer of Common Shares or any securities convertible into Common Shares to the Company upon a vesting event of the Company’s securities or upon the exercise of options to purchase the Company’s securities, in each case on a “cashless” or “net exercise” basis or to cover tax obligations of the undersigned in connection with such vesting or exercise, but only to the extent such right expires during the Lock-up Period, provided that no filing under Section 13 or Section 16(a) of the Exchange Act or other public announcement shall be required or shall be voluntarily made within six months after the date of the Underwriting Agreement, and after such six months, if the undersigned is required to file a report under Section 13 or Section 16(a) of the Exchange Act reporting a reduction in beneficial ownership of Common Shares during the Lock-Up Period, the undersigned shall include a statement in such schedule or report to the effect that the purpose of such transfer was to cover tax withholding obligations of the undersigned in connection with such vesting or exercise and, provided further, that the Plan Shares shall be subject to the terms of this lock-up agreement; (g) the transfer of Lock-Up Securities pursuant to agreements described in the Pricing Prospectus under which the Company has the option to repurchase such securities or a right of first refusal with respect to the transfer of such securities, provided that if the undersigned is required to file a report under Section 13 or Section 16(a) of the Exchange Act reporting a reduction in beneficial ownership of Common Shares during the Lock-Up Period, the undersigned shall include a statement in such schedule or report describing the purpose of the transaction; (h) the establishment of a trading plan pursuant to Rule 10b5-1 under the Exchange Act for the transfer of Lock-Up Securities, provided that (i) such plan does not provide for the transfer of Lock-Up Securities during the Lock-Up Period and (ii) to the extent a public announcement or filing under the Exchange Act, if any, is required of or voluntarily made by or on behalf of the undersigned or the Company regarding the establishment of such plan, such public announcement or filing shall include a statement to the effect that no transfer of Lock-Up Securities may be made under such plan during the Lock-Up Period; (i) the transfer of Lock-Up Securities that occurs by operation of law, such as pursuant to a qualified domestic order or in connection with a divorce settlement, provided that the transferee agrees to sign and deliver a lock-up agreement substantially in the form of this lock-up agreement for the balance of the Lock-Up Period, and provided further, that any filing under Section 13 or Section 16(a) of the Exchange Act that is required to be made during the Lock-Up Period as a result of such transfer shall include a statement that such transfer has occurred by operation of law; and (j) the transfer of Lock-Up Securities pursuant to a bona fide third party tender offer, merger, amalgamation, arrangement, consolidation or other similar transaction made to all holders of the Common Shares involving a change of control (as defined below) of the Company after the closing of the Public Offering and approved by the Company’s board of directors; provided that in the event that the tender offer, merger, amalgamation, arrangement, consolidation or other such transaction is not completed, the Lock-Up Securities owned by the undersigned shall remain subject to the restrictions contained in this lock-up agreement. For purposes of clause (j) above, “change of control” shall mean the consummation of any bona fide third party tender offer, merger, amalgamation, arrangement, consolidation or other similar transaction the result of which is that any “person” (as defined in Section 13(d)(3) of the Exchange Act), or group of persons, becomes the beneficial owner (as defined in Rules 13d-3 and 13d-5 of the Exchange Act) of a majority of total voting power of the voting stock of the Company. The undersigned also agrees and consents to the entry of stop transfer instructions with the Company’s transfer agent and registrar against the transfer of the undersigned’s Lock-Up Securities except in compliance with this lock-up agreement.

 

 Ex. C-1  
 

 

If the undersigned is an officer or director of the Company, (i) the undersigned agrees that the foregoing restrictions shall be equally applicable to any issuer-directed or “friends and family” Securities that the undersigned may purchase in the Public Offering; (ii) the Representative agrees that, at least three (3) business days before the effective date of any release or waiver of the foregoing restrictions in connection with a transfer of Lock-Up Securities, the Representative will notify the Company of the impending release or waiver; and (iii) the Company has agreed in the Underwriting Agreement to announce the impending release or waiver by press release through a major news service at least two (2) business days before the effective date of the release or waiver. Any release or waiver granted by the Representative hereunder to any such officer or director shall only be effective two (2) business days after the publication date of such press release. The provisions of this paragraph will not apply if (a) the release or waiver is effected solely to permit a transfer of Lock-Up Securities not for consideration and (b) the transferee has agreed in writing to be bound by the same terms described in this lock-up agreement to the extent and for the duration that such terms remain in effect at the time of such transfer.

 

The undersigned understands that the Company and the Representative are relying upon this lock-up agreement in proceeding toward consummation of the Public Offering. The undersigned further understands that this lock-up agreement is irrevocable and shall be binding upon the undersigned’s heirs, legal representatives, successors and assigns.

 

The undersigned understands that, if the Underwriting Agreement is not executed by [DATE], or if the Underwriting Agreement (other than the provisions thereof which survive termination) shall terminate or be terminated prior to payment for and delivery of the Common Shares to be sold thereunder, then this lock-up agreement shall be void and of no further force or effect.

 

Whether or not the Public Offering actually occurs depends on a number of factors, including market conditions. Any Public Offering will only be made pursuant to an Underwriting Agreement, the terms of which are subject to negotiation between the Company and the Representative.

 

Very truly yours,

 

____________________________________________________

(Name - Please Print)

 

____________________________________________________

(Signature)

 

____________________________________________________

(Name of Signatory, in the case of entities - Please Print)

 

____________________________________________________

(Title of Signatory, in the case of entities - Please Print)

 

Address: ____________________________________
   
  ____________________________________
   
  ____________________________________

 

 Ex. C-2  
 

 

Exhibit D

 

Form of Press Release

 

BRIACELL THERAPEUTICS CORP.

 

______________, 20___

 

BRIACELL THERAPEUTICS CORP. (the “Company”) announced today that ThinkEquity, a division of Fordham Financial Management, Inc., acting as representative for the underwriters in the Company’s recent public offering of ___________ units of the Company’s securities, is [waiving] [releasing] a lock-up restriction with respect to _________ of the Company’s common shares held by [certain officers or directors] [an officer or director] of the Company. The [waiver] [release] will take effect on _________, 20___, and the shares may be sold on or after such date.

 

This press release is not an offer or sale of the securities in the United States or in any other jurisdiction where such offer or sale is prohibited, and such securities may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act of 1933, as amended.

 

 Ex. D-1  
 

 

Exhibit E

 

Form of Opinion of U.S. Counsel

 

[to be added]

 

 Ex. E-1  
 

 

Exhibit F

 

Form of Opinion of Canadian Counsel

 

[to be added]

 

 Ex. F-1  
 

 

Exhibit G

 

Form of Opinion of Special Intellectual Property Counsel

 

[to be added]

 

 Ex. G-1  
 

 

Exhibit H

 

Form of Opinion of Special Intellectual Property Counsel (Licensing)

 

[to be added]

 

 Ex. H-1  

EX-4.4 3 ex4-4.htm

 

Exhibit 4.4

 

UNLESS PERMITTED UNDER SECURITIES LEGISLATION, THE HOLDER OF THIS SECURITY AND ANY SECURITY ISSUED ON CONVERSION HEREOF MUST NOT TRADE THE SECURITY BEFORE MARCH 17, 2021.

 

THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “U.S. SECURITIES ACT”) OR U.S. STATE SECURITIES LAWS. THESE SECURITIES MAY BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED, DIRECTLY OR INDIRECTLY, ONLY (A) TO BRIACELL THERAPEUTICS CORP. (THE “CORPORATION”), (B) OUTSIDE THE UNITED STATES IN COMPLIANCE WITH RULE 904 OF REGULATION S UNDER THE U.S. SECURITIES ACT AND IN COMPLIANCE WITH APPLICABLE LOCAL LAWS AND REGULATIONS, (C) IN COMPLIANCE WITH THE EXEMPTION FROM THE REGISTRATION REQUIREMENTS UNDER THE U.S. SECURITIES ACT PROVIDED BY (I) RULE 144 THEREUNDER IF AVAILABLE OR (II) RULE 144A THEREUNDER, IF AVAILABLE, AND IN EACH CASE IN ACCORDANCE WITH APPLICABLE U.S. STATE SECURITIES LAWS, (D) IN ANOTHER TRANSACTION THAT DOES NOT REQUIRE REGISTRATION UNDER THE U.S. SECURITIES ACT OR ANY APPLICABLE STATE SECURITIES LAWS, OR (E) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE U.S. SECURITIES ACT, PROVIDED THAT, IN THE CASE OF TRANSFERS PURSUANT TO (C)(I) OR (D) ABOVE, THE HOLDER HAS, PRIOR TO SUCH TRANSFER, FURNISHED TO THE CORPORATION AN OPINION OF COUNSEL OR OTHER EVIDENCE OF EXEMPTION, IN EITHER CASE REASONABLY SATISFACTORY TO THE CORPORATION. DELIVERY OF THIS CERTIFICATE MAY NOT CONSTITUTE “GOOD DELIVERY” IN SETTLEMENT OF TRANSACTIONS ON STOCK EXCHANGES IN CANADA.

 

BRIACELL THERAPEUTICS CORP.

 

UNSECURED CONVERTIBLE DEBENTURE

 

PRINCIPAL AMOUNT: $375,000

PURCHASE PRICE: $265,000

Date: November 16, 2020

 

1.Promise to Pay FOR VALUE RECEIVED, the undersigned, BriaCell Therapeutics Corp. (the “Corporation”) hereby acknowledges itself indebted and promises to pay to or to the order of Evergreen Capital Management LLC, 156 W Saddle River Road, Saddle River, NJ 07458 (herein referred to as the the “Debentureholder”), the principal amount of $375,000 (the “Principal Amount”), such Principal Amount having a purchase price of $265,000 after being reduced by an original issuance discount equal to approximately 29.33%, in lawful money of Canada, at the foregoing address of the Debentureholder, or at such other place, places and/or person as the Debentureholder may direct by notice in writing to the Corporation, and to pay interest in the amount of 5% per annum to the Debentureholder on the Principal Amount outstanding from time to time, and perform all other Obligations (as hereafter defined), subject to the terms and conditions contained herein.

 

   
   

 

2.Definitions and Interpretation

 

2.1As used herein, the following terms shall have the following respective meanings, unless the context otherwise requires:

 

Affiliate” has the meaning ascribed to such term in the Business Corporations Act (Ontario), as in effect on the date of this Debenture.

 

Business Day” means any day except Saturday, Sunday or any other day on which the principal chartered banks in the City of Toronto, Ontario, Canada are not open for business.

 

Common Share Reorganization” shall have the meaning ascribed to such term in Section 7.

 

Common Shares” means fully-paid and non-assessable common shares in the capital of the Corporation as constituted on the date hereof, and after the date hereof any other shares, other securities, money or property which the Debentureholder is entitled to receive in respect or substitution thereof upon conversion of this Debenture pursuant to Section 6.

 

Conversion Date” means the date on which the Debenture is received by the Corporation for conversion in accordance with the terms and conditions in Section 6.

 

Conversion Price” means, subject to adjustment as provided in Section 7, $5.42 per Common Share.

 

Corporation” means BriaCell Therapeutics Corp., a corporation incorporated under the laws of the Province of British Columbia and includes any successor to or of the Corporation which shall have complied with the provisions of Section 14.

 

Credit Documents” means, collectively, the Debentures and all certificates, notices, agreements and other documents delivered to the Debentureholder, or entered into by the Debentureholder pursuant to or in connection with the Debentures;

 

CSE” means the Canadian Securities Exchange.

 

Current Market Price” shall have the meaning ascribed to the term in Section 7.1(d).

 

Debenture” means this unsecured convertible debenture as it may be amended, supplemented or restated from time to time and “Debentures” means the aggregate of up to $375,000 in principal amount of Debentures (inclusive of an original discount equal to approximately 29.33%, and for greater certainty, including this Debenture) issued pursuant to the Offering.

 

Debentureholder” shall have the meaning ascribed to such term in the introductory paragraph hereto.

 

  2.
   

 

Dividends Paid in the Ordinary Course” means cash dividends declared payable on the Common Shares in any fiscal year of the Corporation to the extent that such cash dividends do not exceed, in the aggregate, an amount greater than:

 

(a)fifty (50%) percent of the retained earnings of the Corporation as at the end of its immediately preceding fiscal year; and

 

(b)one hundred (100%) percent of the aggregate consolidated net income of the Corporation, determined before computation of extraordinary items, for its immediately preceding fiscal year;

 

Encumbrance” means any mortgage, charge, pledge, hypothecation, lien, assignment, lease intended as security, conditional sale agreement or other title retention arrangement, security interest or other encumbrance of any nature creating in favour of any Person a right or interest in respect of real or personal property that is prior to the right of any other creditor or claimant in respect of such property;

 

Event of Default” shall have the meaning ascribed to such term in Section 8.2.

 

Expiration Time” means 5:00 pm (Toronto time) on the Maturity Date.

 

Indebtedness” means, at any time and from time to time, all of the Principal Amount, any accrued and unpaid interest and any other amount owing pursuant to this Debenture, including any Prepayment Penalty and/or Default Penalty, in each case which has not been paid to the Debentureholder by the Corporation.

 

Interest Rateshall have the meaning ascribed to such term in Section 4.1.

 

Maturity Date” means the earlier of (i) November 16, 2025, (ii) the date the Corporation completes a Qualified Financing, or (iii) such earlier date as the principal amount hereof may become due, subject to and in accordance with the terms, conditions and provisions hereof, subject to extension upon mutual agreement of the parties.

 

Material Adverse Change” means a material adverse effect on (i) the ability of the Corporation to pay its obligations hereunder as and when due; (ii) the business, operation, prospects, assets or condition, financial or otherwise, of the Corporation or any Subsidiary; or (iii) the ability of the Corporation or any Subsidiary to perform any other material obligations to the Debentureholder under this Debenture or any other present or future agreements in respect of the property and assets of the Corporation.

 

Obligations” means all Indebtedness, liability and other obligations of the Corporation hereunder or under the Subscription Agreement and any other agreement between the Corporation and the Debentureholder.

 

Offered Securities” any equity or voting securities, or securities convertible into or exchangeable for equity or voting securities, of the Corporation;

 

Offering” means the private placement offering of $365,000 in aggregate principal amount of Debentures by the Corporation pursuant to a subscription agreement entered into between the Corporation and the Debentureholder;

 

  3.
   

 

Person” includes an individual, a trust, a partnership, a body corporate or politic, a syndicate, a joint venture, a company, an association and any other form of incorporated or unincorporated organization or entity.

 

Principal Amount” has the meaning ascribed thereto in Section 1.

 

Qualified Financing” means the sale by the Corporation of $2,000,000 or more of Offered Securities in the aggregate, in one or more closings or tranches.

 

“Recognized Exchange” means the New York Stock Exchange, the NASDAQ Capital Market, the NASDAQ Global Select Market, the NASDAQ Global Market, the CSE, the TSX Venture Exchange or the Toronto Stock Exchange.

 

Rights Offering” shall have the meaning ascribed to such term in Section 7.

 

Securities Laws” means, collectively, the applicable securities laws of the relevant jurisdictions, the regulations, rules, rulings and orders made thereunder, the applicable policy statements issued by the securities regulators thereunder, the securities legislation and policies of each other relevant jurisdiction and the rules of the relevant stock exchange, in each case in effect from time to time.

 

Special Distribution” shall have the meaning ascribed to such term in Section 7.

 

Subscription Agreement” means a Subscription Agreement of even date between the Corporation and the Debentureholder providing for the issuance of the Debenture of the Corporation, as it may be amended, supplemented or restated from time to time.

 

Subsidiary” means a business entity which is controlled, directly or indirectly by another business entity (as used herein “business entity” includes a corporation, company, partnership, limited partnership, trust or joint venture).

 

Warrants” means the Common Share purchase warrants issued by the Corporation to the Debentureholder on or about the date hereof.

 

2.2Interpretation

 

Words importing the singular only shall include the plural and vice versa, words importing the masculine gender shall include the feminine gender and words importing persons shall include firms and corporations and vice versa.

 

2.3Headings

 

The division of this Debenture into Articles and Sections and the use of headings are for convenience of reference only and shall not affect the construction or interpretation of this Debenture.

 

2.4Time of Essence

 

Time is of the essence of this Debenture.

 

  4.
   

 

2.5Currency

 

Unless otherwise specified, all dollar amounts in this Debenture, including the symbol “$”, refer to Canadian currency.

 

2.6Business Day

 

If the date upon which any amount is payable by the Corporation, or upon which any other action is required to be taken by the Corporation hereunder, is not a Business Day, then such amount shall be payable or such other action shall be taken on or by the next succeeding Business Day.

 

3.Payment

 

(a)Unless the Indebtedness is redeemed or converted in accordance with this Debenture, the Corporation shall pay to the Debentureholder the Indebtedness on the Maturity Date.

 

(b)Upon the Principal Amount and interest (including interest on amounts in default, if any) on this Debenture and all other money payable hereunder having been paid or satisfied, the Debentureholder shall, at the request of the Corporation, release and discharge this Debenture. Upon such request, the Debentureholder shall execute and deliver such instruments as it shall be advised by the Corporation’s counsel are requisite to release the Corporation from its covenants herein contained.

 

4.Interest

 

4.1The Principal Amount and any penalties, including the Prepayment Penalty (as defined herein) and the Default Penalty (as defined herein) outstanding shall bear interest at a rate of 5% (subject to Section 4.2) per annum (the “Interest Rate”), calculated and payable, in cash, not in advance, accrued from the date hereof and payable on the Maturity Date.

 

4.2Upon an Event of Default, the Interest Rate shall increase to 12% per annum from the date of the Event of Default until the date such Event of Default is cured.

 

4.3Notwithstanding the foregoing provisions of this Section 4, or anything contained herein, or in any document entered into in connection herewith to the contrary, in the event that any provision of this Debenture or any document entered into in connection herewith would oblige the Corporation to make any payment of interest or other amount payable to the Purchaser in an amount or calculated at a rate which would be prohibited by any Applicable Law or would result in the receipt by the Purchaser of interest at a criminal or prohibited rate (as such terms are construed under the Criminal Code (Canada) or any other Applicable Law), then notwithstanding such provision, such amount or rate shall be deemed to have been adjusted with the same effect as if adjusted at the original date of this Debenture to the maximum amount or rate of interest, as the case may be, as would not be so prohibited by any Applicable Law or so result in the receipt by the Purchaser of interest at a criminal or prohibited.

 

  5.
   

 

5.Redemption by the Corporation

 

5.1Subject to Section 6, the Corporation may, at its option, subject to providing not less than 30 days prior written notice to the Debentureholder, prepay any amount of the Principal Amount of the Debenture during the 120 period following the date of this Debenture, without penalty (“Redemption”). After 120 days following the date of this Debenture, and only if the Corporation elects to prepay the Debenture prior to November 16, 2021 the Corporation is required to pay a prepayment penalty equal to 35% of the Principal Amount of the Debenture (the “Prepayment Penalty”). For greater certainty, the Prepayment Penalty shall only be satisfied by the Corporation in cash and the Corporation shall not under any circumstances satisfy the Prepayment Penalty with the issuance of Common Shares.

 

6.Conversion by the Debentureholder

 

6.1Subject to the provisions of this Debenture, including Section 5.1 and Section 8.3 of this Debenture and any regulatory approval, the Debentureholder shall have the right, at the option of the Debentureholder during the period beginning on May 16, 2021, to the close of business on the Business Day before the Maturity Date, and the Business Day preceding the date fixed for Redemption (the “Conversion Date”), to elect to convert a part, or all, of the Indebtedness then outstanding into Common Shares at the Conversion Price, subject to adjustment in certain events as described in Section 7 (“Conversion Right”).

 

6.2In no event shall the Conversion Right of this Debenture exceed five (5) years following the date hereof.

 

6.3Fractional Common Shares will not be issued on any conversion and if any fractional Common Shares would be delivered upon conversion of any amount hereunder, the number of Common Shares to be issued shall be rounded down to the nearest whole Common Share. If the Debentureholder desires to convert the Indebtedness, subject to Section 5.1 and Section 8.3 of this Debenture, it shall send to the Corporation prior to the date on which the Indebtedness is to be converted into Common Shares (the “Exercise Date”) a notice, in the form of Schedule “A” (the “Conversion Notice”), of the conversion specifying the Exercise Date and the number of Common Shares to be issued upon conversion. On the Exercise Date, the Debentureholder shall be entered in the books of the Corporation as the holder of the number of Common Shares resulting from the conversion and shall be treated for all purposes (including the right to receive dividends) as the holder of record of such Common Shares which shall be deemed outstanding as fully paid and non-assessable. The Corporation must maintain at all times sufficient authorized but unissued Common Shares solely for the purpose of issue upon exercise of the Conversion Right in accordance with the terms hereof, and conditionally allot to the Debentureholder, such number of Common Shares as shall then be issuable upon the conversion of any portion of the Indebtedness, subject to Section 5.1 and Section 8.3 of this Debenture, and the Corporation covenants with the Debentureholder that all Common Shares which shall be so issuable pursuant to the Conversion Right shall be duly and validly issued as fully paid and non-assessable.

 

  6.
   

 

6.4If the Debentureholder sends a Conversion Notice, the Debentureholder must thereafter surrender this Debenture to the Corporation in exchange for Common Share certificates (the “Share Certificates”) of Corporation in the name of Debentureholder evidencing the ownership of that number of Common Shares specified in the Conversion Notice. As soon as practicable after the surrender of this Debenture by the Debentureholder to the Corporation (but in no event prior to the Exercise Date), the Corporation shall deliver or arrange for the delivery of the Share Certificates (or a DRS Advice in lieu of the Share Certificates) to the Debentureholder. In the event of the conversion of this Debenture in part, the Corporation shall, without charge, forthwith execute and deliver to the Debentureholder a new debenture in a principal amount equal to the unconverted part of this Debenture so surrendered in the same form as this Debenture, except as to Principal Amount.

 

6.5If the Debentureholder fails to surrender this Debenture within five (5) days from the Exercise Date, the Share Certificates will be set aside in trust for the Debentureholder and such setting aside shall for all purposes be deemed to satisfy the Corporation’s obligations to the Debentureholder pursuant to this Section 6 and the Debentureholder shall have no right, except upon surrender of this Debenture to the Corporation, to receive the Share Certificates.

 

6.6The Corporation shall deliver the Share Certificate as soon as reasonably possible, but not later than three (3) Business Days following the receipt of the original Debenture from the Debentureholder.

 

7.Adjustment of Conversion Price

 

7.1The Conversion Price in effect at any date shall be subject to adjustment from time to time as follows:

 

(a)If and whenever at any time after the date hereof and prior to the Expiration Time the Corporation shall:

 

(i)issue Common Shares or securities exchangeable for or convertible into Common Shares to all or substantially all of the Corporation’s shareholders as a stock dividend or make a distribution on its outstanding Common Shares (other than as Dividends Paid in the Ordinary Course);

 

(ii)subdivide or redivide its outstanding Common Shares into a greater number of Common Shares; or

 

(iii)consolidate, reduce or combine its outstanding Common Shares into a smaller number of Common Shares;

 

(each of the events enumerated in the clauses (i), (ii) and (iii), above, being hereinafter referred to as a “Common Share Reorganization”), the Conversion Price shall be adjusted effective immediately after the record date or effective date, as the case may be, which is used to determine the holders of outstanding Common Shares for the happening of a Common Share Reorganization, by multiplying the Conversion Price in effect immediately prior to such record date or effective date by a fraction, the numerator of which shall be the number of Common Shares outstanding on such record date or effective date, as the case may be, before giving effect to such Common Shares Reorganization, and the denominator of which shall be the number of Common Shares outstanding as of the effective date or record date, as the case may be, after giving effect to such Common Share Reorganization (including, in the case where securities exchangeable for or convertible into Common Shares are distributed, the number of Common Shares that would have been outstanding had such securities been fully exchanged or exercised for or converted into Common Shares on such record date or effective date, as the case may be).

 

  7.
   

 

(b)If and whenever at any time after the date hereof and prior to the Expiration Time, the Corporation shall fix a record date for the issuance of rights, options or warrants to all or substantially all of the holders of the outstanding Common Shares with respect to the payment of dividends or the return of capital, including the Common Shares pursuant to which such shareholders are entitled, directly or indirectly, during a period expiring not less than 21 days and not more than 90 days after such record date (the “Rights Period”), to subscribe for or purchase Common Shares at a price per share to the holder of less than 95% of the Current Market Price on such record date or to subscribe for or purchase securities (in this paragraph (b) referred to as “Exchangeable Securities”) exchangeable or exercisable for or convertible into Common Shares at an effective subscription price per Common Shares (giving effect to the terms of such subscription or purchase and of such exchange or conversion privilege) of less than 95% of the Current Market Price on such record date (any of such events being hereinafter called a “Rights Offering”), then the Conversion Price shall be adjusted effective immediately after the end of the Rights Period to a price determined by multiplying the Conversion Price in effect immediately prior to the end of the Rights Period by a fraction:

 

(i)the numerator of which shall be the aggregate of:

 

(A)the number of Common Shares outstanding as of the record date for the Rights Offering, and

 

(B)a number determined by dividing: (I) either (1) the product of the number of Common Shares issued or subscribed for during the Rights Period and the price per share at which such Common Shares are acquired; or, as the case may be, (2) the product of the exchange, exercise or conversion price of the Exchangeable Securities and the maximum number of Common Shares for or into which such Exchangeable Securities distributed under the Rights Offering may be exchanged, exercised or converted; by (II) the Current Market Price as of the record date for the Rights Offering; and

 

(ii)the denominator of which shall be the number of Common Shares outstanding immediately after the end of the Rights Period (after giving effect to the Rights Offering, including the number of Common Shares actually issued or subscribed for during the Rights Period upon exercise of the rights, warrants or options distributed under the Rights Offering and the number of Common Shares that would have been issued had all Exchangeable Securities been exchanged or exercised for or converted into Common Shares).

 

  8.
   

 

For the purposes of any computation made in accordance with this subsection 7.1(b), Common Shares owned legally or beneficially by the Corporation or a subsidiary or any other affiliate (as such terms are defined in the Securities Act (Ontario)) of the Corporation shall be disregarded. To the extent that any adjustment in the Conversion Price occurs pursuant to this subsection 7.1(b) as a result of the fixing by the Corporation of a record date for the issue or distribution of rights, options or warrants referred to in this subsection 7.1(b), the Conversion Price shall be readjusted immediately after the expiry of any relevant exchange, conversion or exercise right to the Conversion Price which would then be in effect based upon the number of Common Shares actually issued and remaining issuable after such expiry and shall be further readjusted in such manner upon the expiry of any further such right.

 

(c)If and whenever at any time after the date hereof and prior to the Expiration Time the Corporation shall fix a record date for the issue or the distribution to all or substantially all of the holders of one or more classes of outstanding Common Shares of: (i) shares of any class other than Common Shares; (ii) rights, options or warrants to acquire Common Shares or securities exchangeable for or convertible into Common Shares (excluding those referred to in Section 7.1(b)); (iii) evidences of the Corporation’s indebtedness; or (iv) any property or other assets (including cash), and if such issuance or distribution does not constitute Dividends Paid in the Ordinary Course, a Common Share Reorganization or a Rights Offering (any of such non-excluded events being herein called a “Special Distribution”), the Conversion Price shall, subject to the prior written approval of any stock exchange or over-the-counter market on which the Common Shares are then listed or quoted for trading, if required, be adjusted effective immediately after such record date to a price determined by multiplying the Conversion Price in effect on such record date by a fraction:

 

(i)the numerator of which shall be:

 

(A)the product obtained when the number of Common Shares outstanding on such record date is multiplied by the Current Market Price on such record date; less

 

(B)the excess, if any, of (1) the fair market value, as determined by action by the directors of the Corporation (whose determination shall be conclusive), which action shall be subject to the prior written approval of any stock exchange or over-the-counter market on which the Common Shares are then listed or quoted for trading, if required, to the holders of the Common Shares of the shares, rights, options, warrants, evidences of indebtedness or property or other assets issued or distributed in the Special Distribution, over (2) the fair market value of any consideration received therefore by the Corporation from the holders of the Common Shares, as determined by action by the directors of the Corporation (whose determination shall be conclusive); and

 

  9.
   

 

(ii)the denominator of which shall be the product obtained when the number of Common Shares outstanding on such record date is multiplied by the Current Market Price on such record date.

 

To the extent that such distribution is not so made, the Conversion Price shall be readjusted to the Conversion Price which would then be in effect if such record date had not been fixed or to the Conversion Price which would then be in effect based upon such shares or rights, options or warrants or evidences of indebtedness or assets actually distributed.

 

For the purposes of any computation made in accordance with this subsection 7.1(c), Common Shares owned legally or beneficially by the Corporation or a subsidiary or any other affiliate (as such terms are defined in the Securities Act (Ontario)) of the Corporation shall be disregarded.

 

(d)For the purpose of any computation under this Debenture, the “Current Market Price” in respect of a Common Share at any date means the volume weighted average price per share for the 10 consecutive trading days ending not more than three business days before such date when the securities are listed on the facilities of the TSX Venture Exchange, or if the Common Shares are not then listed on the TSX Venture Exchange, on such other stock exchange on which the Common Shares trade as may be selected by the directors of the Corporation for such purpose; the volume weighted average price shall be determined by dividing the aggregate of the sale prices of all such shares sold on such exchange, during such 10 consecutive trading days by the total number of such shares so sold; or if:

 

(i)the Common Shares are not listed upon a nationally-recognized stock exchange; or

 

(ii)within such 10 consecutive trading days there have not been at least five days in which at least 100 Common Shares have traded,

 

the Current Market Price in respect of a Common Share shall be determined by the directors of the Corporation acting reasonably and in good faith;

 

(e)In any case in which Section 7 shall require that an adjustment become effective immediately after a record date or agreement date for an event referred to herein, the Corporation may defer, until the occurrence of such event, issuing or transferring to the Debentureholder who converts on a Conversion Date after such record date or agreement date and before the occurrence of such event the additional Common Shares issuable upon such conversion by reason of the adjustment of the Conversion Price required by such event before giving effect to such adjustment provided, however, that the Corporation shall deliver to the Debentureholder an appropriate instrument evidencing the Debentureholder’s right to receive such additional Common Shares upon the occurrence of the event requiring such adjustment and the right to receive any distributions made on such additional Common Shares declared in favour of holders of record of such Common Shares on and after the Conversion Date or such later date as such Debentureholder would, but for the provisions of this Section 7.1(e), have become the holder of record of such additional Common Shares.

 

  10.
   

 

(f)The adjustments provided for in Section 7 are cumulative and shall apply to successive subdivisions, re-divisions, reductions, combinations, consolidations, distributions, issues or other events resulting in any adjustment under the provisions of this Section, provided that, notwithstanding any other provision of this Section, no adjustment of the Conversion Price shall be required unless such such adjustment would require an increase or decrease of at least one percent (1%) in the Conversion Price then in effect;.

 

(g)In the event of any dispute arising with respect to the adjustments provided in Section 7, such question shall be conclusively determined by the auditors of the Corporation) who shall have access to all necessary records of the Corporation and such determination shall be binding upon the Corporation and the Debentureholder.

 

(h)If any Common Shares to be issued upon the conversion of this Debenture hereunder require any filing with, or registration with or approval of any governmental authority or compliance with any other requirement under any law before such shares may be validly issued upon such conversion or traded by the person to whom they are issued pursuant to such conversion, the Corporation will take all action as may be necessary to secure such filing, registration, approval or compliance, as the case may be.

 

(i)Notwithstanding the foregoing, nothing in Section 7 shall in any manner compromise or derogate from any rights the Debentureholder may have to approve any transaction contemplated by Section 7, whether in its capacity as a shareholder (if applicable), as a Debentureholder or otherwise.

 

(j)No adjustment in the Conversion Price shall be made in respect of any event described in Sections 7.1(a), other than the events referred to in clauses 7.1(a)(i) and 7.1(a)(iii), if the Debentureholder is, without converting this Debenture, entitled to participate in such event on the same terms mutatis mutandis as if the Debentureholder had received Common Shares as a result of having converted this Debenture prior to or on the effective date or record date of such event; provided that such participation shall be subject to receipt of all necessary regulatory approvals.

 

(k)Notwithstanding anything in this 7.1, no adjustment shall be made in the conversion rights attached to this Debenture if the issue of Common Shares is being made in connection with any share incentive plan or restricted share unit plan or share purchase plan in force from time to time for directors, officers, employees, consultants or other service providers of the Corporation.

 

(l)If in the opinion of the directors of the Corporation the provisions of Section 7 are not strictly applicable, or if strictly applicable would not fairly protect the rights of the Debentureholder in accordance with the intent and purposes hereof, the directors of the Corporation shall make any adjustment in such provisions as the directors of the Corporation deems appropriate, acting reasonably, for the benefit of the Debentureholder.

 

  11.
   

 

7.2Reclassifications, Reorganizations, etc. In case of any amalgamation of the Corporation with, or merger of the Corporation into, any other corporation with the result that the Corporation ceases to exist in its present capacity, or in case of any sale, transfer or other disposition of all or substantially all of the assets of the Corporation, the successor corporation or holder of the corporation’s assets as the case may be shall, and the Corporation shall cause such successor corporation or holder of the corporation’s assets to, give notice in the manner specified in Section 18 to the Debentureholder. Such notice shall confirm that the Debentureholder shall have the right to convert the Debenture into the kind and amount of Common Shares and other securities and property receivable upon such amalgamation, merger or sale such holder would have been entitled to receive as a result of such amalgamations, mergers, sales, transfers or other dispositions, if, on the effective date thereof, the Debentureholder had been the registered holder of the number of Common Shares to which it was until then entitled upon conversion of the Debenture. Such notice shall confirm adjustments which shall be as nearly equivalent as may be practicable to the adjustments provided for in this Section. The above provisions of this Section 7.2 shall similarly apply to successive amalgamations, mergers, sales, transfers or other dispositions.

 

7.3Certificates as to Adjustment The Corporation shall from time to time forthwith after the occurrence of any event which requires adjustment or readjustment as provided in Section 7, deliver to the Debentureholder, an officer’s certificate specifying the nature of the event requiring the adjustment or readjustment and the amount of the adjustment or readjustment necessitated thereby and setting forth in reasonable detail the method of calculation and the facts upon which such calculation is based.

 

7.4Notice of Special Matters The Corporation covenants that so long as this Debenture remains outstanding, it will give notice to the Debentureholder at the address provided for in Section 18, of its intention to fix a record date or agreement date for any event which may give rise to an adjustment in the Conversion Price and, in each case, such notice shall specify the particulars of such event and the record date, the agreement date and the effective date for such event, provided that the Corporation shall only be required to specify in such notice such particulars of such event as shall have been fixed and determined on the date on which such notice is given. Such notice shall be given not less than seven (7) Business Days in each case prior to such applicable record date. The Corporation shall not during the period of such notice close the transfer books for Common Shares so as to prevent the conversion of this Debenture or fix a record date for voting so as to prevent the Common Shares resulting from a conversion of this Debenture from being voted. Nothing in this Section 7.4 shall in any manner derogate from or compromise the Debentureholder’s rights to receive notice pursuant to any applicable laws.

 

  12.
   

 

8.Covenants and Events of Default and Representations

 

8.1Covenants The Corporation covenants and agrees, on its own behalf and on behalf of each Subsidiary (where applicable) with the Debentureholder that, so long as this Debenture is outstanding and in force and except as otherwise permitted by the prior written consent of the Debentureholder:

 

(a)To Pay Principal and Interest: The Corporation will duly and punctually pay or cause to be paid to the Debentureholder the Principal Amount and interest accrued on the Debentures, at the places and in the manner mentioned herein and in the Debentures.

 

(b)Notice of Event of Default: The Corporation shall forthwith notify the Debentureholder of the occurrence of any Event of Default or any event of which it is aware which with notice or lapse of time or both would constitute an Event of Default together with full details and any action proposed to be taken.

 

(c)Preservation of Existence, etc: Subject to the express provisions hereof, the Corporation will carry on and conduct its activities, and cause its Subsidiaries to carry on and conduct their business, in a business-like manner and in accordance with good business practices; and, subject to the express provisions hereof, it will do or cause to be done all things necessary to preserve and keep in full force and effect its existence and rights.

 

(d)Keeping of Books: The Corporation will keep or cause to be kept proper books of record and account, in which full and correct entries shall be made of all financial transactions and the assets and business of the Corporation and each Subsidiary in accordance with generally accepted accounting principles.

 

(e)Maintain Listing: The Corporation will maintain the listing of the Common Shares on the TSX Venture Exchange or other Recognized Exchange, and to maintain the Corporation’s status as a “reporting issuer” not in default of the requirements of the applicable Securities Laws; provided that the foregoing covenant shall not prevent or restrict the Corporation from carrying out a transaction to which Section 14 would apply if carried out in compliance with Section 14 even if as a result of such transaction the Corporation ceases to be a “reporting issuer” in all or any of the provinces of Canada or the Common Shares cease to be listed on the TSX Venture Exchange or any other stock exchange.

 

(f)Withholding Matters: All payments made by or on behalf of the Corporation under or with respect to the Debentures (including, without limitation, any penalties, interest and other liabilities related thereto) will be made free and clear of and without withholding, or deduction for, or on account of, any present or future tax, duty, levy, impost, assessment or other governmental charge (including, without limitation, penalties, interest and other liabilities related hereto) imposed or levied by or on behalf of the Government of Canada or the United States or elsewhere, or of any province or territory thereof or by any authority or agency therein or thereof having power to tax (“Withholding Taxes”), unless the Corporation is required by law or the interpretation or administration thereof, to withhold or deduct any amounts for, or on account of Withholding Taxes. If the Corporation is so required to withhold or deduct any amount for, or on account of, Withholding Taxes from any payment made under or with respect to the Debentures, the Corporation shall deduct and withhold such Withholding Taxes from any payment to be made or with respect to the Debentures and, provided that the Corporation forthwith remits such amount to the relevant governmental authority or agency, the amount of any such deduction or withholding will be considered an amount paid in satisfaction of the Corporation’s obligations under the Debentures. There is no obligation on the Corporation to gross-up or pay additional amounts to a holder of Debentures in respect of such deductions or withholdings. For greater certainty, if any amount is required to be deducted or withheld in respect of Withholding Taxes upon a conversion of a Debenture, the Corporation shall be entitled to liquidate such number of Common Shares (or other securities) issuable as a result of such conversion as shall be necessary in order to satisfy such requirement. The Corporation shall provide the Debentureholder with copies of receipts or other communications relating to the remittance of such withheld amount or the filing of any forms received from such government authority or agency promptly after receipt thereof.
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(g)No Encumbrances: The Corporation shall not permit any lien or Encumbrance to be made or exist upon its property and assets.

 

(h)No Material Change of Business: The Corporation will notify the Debentureholder in the event of any Material Adverse Change. The Corporation will notify the Debentureholder in the event it receives notice of any regulatory, governmental or criminal citation, notice of violation, investigation or proceeding that may have a material impact on the Corporation’s license, business activities or operations. The Corporation will notify the Debentureholder in the event it receives notice of any non-compliance citations or notices of violations, of which the Corporation is aware, that may have a material impact on the investee’s, supplier’s or customers’ license, business activities or operations.

 

(i)Securities Law Disclosure, Publicity: The Corporation shall, by 9:30 a.m. (Toronto time) on the Business Day immediately following the date hereof, issue a press release disclosing the material terms of the transactions contemplated hereby. From and after the issuance of such press release, the Corporation represents to the Debentureholder that it shall have publicly disclosed all material, non-public information in connection with the transaction contemplated by the Credit Documents. The Corporation and Debentureholder shall consult with each other in issuing any other press releases with respect to the transactions contemplated hereby, and neither the Corporation nor any Debentureholder shall issue any such press release nor otherwise make any such public statement without the prior consent of the Corporation, with respect to any press release of any Debentureholder, or without the prior consent of each Debentureholder, with respect to any press release of the Corporation, which consent shall not unreasonably be withheld or delayed, except if such disclosure is required by law, in which case the disclosing party shall promptly provide the other party with prior notice of such public statement or communication. The Corporation shall not, and shall cause each of its Subsidiaries and each of their respective officers, directors, employees, affiliates and agents, not to, provide any Debentureholder with any material, nonpublic information regarding the Corporation or any of its Subsidiaries from and after the date hereof without the express prior written consent of such Debentureholder.

 

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If a Debentureholder has, or believes it has, received any such material, nonpublic information regarding the Corporation or any of its Subsidiaries from the Corporation, any of its Subsidiaries or any of their respective officers, directors, employees, affiliates or agents, it may provide the Corporation with written notice thereof. The Corporation shall, within one (1) Business Day of receipt of such notice, make public disclosure of such material, nonpublic information. In the event of a breach of the foregoing covenant by the Corporation, any of its Subsidiaries, or any of its or their respective officers, directors, employees, affiliates and agents, in addition to any other remedy provided herein or in the Transaction Documents, a Debentureholder shall have the right to make a public disclosure, in the form of a press release of such material, nonpublic information. No Debentureholder shall have any liability to the Corporation, its Subsidiaries, or any of its or their respective officers, directors, employees, affiliates, stockholders or agents for any such disclosure. To the extent that the Corporation delivers any material, nonpublic information to a Debentureholder without such Debentureholder’s consent, the Corporation hereby covenants and agrees that such Debentureholder shall not have any duty of confidentiality to the Corporation, any of its Subsidiaries or any of their respective officers, directors, employees, affiliates or agent with respect to, or a duty to the Corporation, any of its Subsidiaries or any of their respective officers, directors, employees, affiliates or agent not to trade on the basis of, such material, nonpublic information. Notwithstanding the foregoing, the Corporation shall not publicly disclose the name of any Debentureholder, or include the name of any Debentureholder in any filing with the any regulatory agency or the TSX Venture Exchange, without the prior written consent of such Debentureholder, except: (a) as required by Securities Law in connection with the filing of final Credit Documents with the TSX Venture Exchange and (b) to the extent such disclosure is required by Securities Laws, in which case the Corporation shall provide the Debentureholders with prior notice of such disclosure permitted under this clause (b).

 

8.2Events of Default Unless waived in writing by the Debentureholder, any one or more of the following events shall constitute an Event of Default hereunder:

 

(a)failure for 10 Business Days to pay interest on the Debentures when due;

 

(b)failure to pay the outstanding Principal Amount (whether by way of payment of cash or delivery of Common Shares), if any, when due on the Debentures whether at maturity, upon redemption, by declaration or otherwise;

 

(c)default in the delivery, when due, of any Common Shares or other consideration, payable on conversion with respect to the Debentures, which default continues for three (3) Business Days;

 

(d)default in the observance or performance of any covenant or condition of the Debenture by the Corporation and such default, if capable of being remedied, is not remedied within 10 Business Days;

 

  15.
   

 

(e)if a decree or order of a Court having jurisdiction is entered adjudging the Corporation a bankrupt or insolvent under the Bankruptcy and Insolvency Act (Canada) or any other bankruptcy, insolvency or analogous laws, or issuing sequestration or process of execution against, or against any substantial part of, the property of the Corporation, or appointing a receiver of, or of any substantial part of, the property of the Corporation or ordering the winding-up or liquidation of its affairs, and any such decree or order continues unstayed and in effect for a period of 60 days;

 

(f)if the Corporation institutes proceedings to be adjudicated a bankrupt or insolvent, or consents to the institution of bankruptcy or insolvency proceedings against it under the Bankruptcy and Insolvency Act (Canada) or any other bankruptcy, insolvency or analogous laws, or consents to the filing of any such petition or to the appointment of a receiver of, or of any substantial part of, the property of the Corporation, or any Subsidiary or makes a general assignment for the benefit of creditors, or admits in writing its inability to pay its debts generally as they become due;

 

(g)if, after the date of this Debenture, the Corporation or any of its Subsidiaries issues a convertible security or equity-linked security (whether such debt begins with a convertible feature or such feature is added at a later date) with any term more favorable to the holder of such security or with a term in favor of the holder of such security that was not similarly provided to the Debentureholder in this Debenture, including the issuance of warrants or extent of warrant coverage even if merely based on a reduction of the conversion price or original issuance discount, or more favorable terms than the Warrants, (types of terms contained in the other security that may be more favorable to the holder of such security include, but are not limited to, terms addressing conversion discounts, conversion look back periods, interest rates, original issue discount percentages and warrant coverage);

 

(h)if, after the date of this Debenture, any proceedings with respect to the Corporation are taken with respect to a compromise or arrangement, with respect to creditors of the Corporation generally, under the applicable legislation of any jurisdiction; or

 

(i)if the Corporation fails to complete a Qualified Financing by September 16, 2021.

 

8.3Acceleration and Penalty Upon the occurrence of any one or more of the Events of Default:

 

(a)a penalty payment equal to 40% of the Principal Amount of the Debenture will be added to the Principal Amount of the Debenture (the “Default Penalty”) and such Default Penalty, if applicable, shall be satisfied by the Corporation in cash, and the Corporation shall not under any circumstances satisfy the Default Penalty with the issuance of Common Shares; and

 

(b)the Indebtedness outstanding at that time shall be accelerated, and shall become immediately due and payable at the option of the Debentureholder. Alternatively, upon the occurrence of any one or more of the Events of Default, the Debentureholder may, by giving written notice thereof to the Corporation, elect to convert, subject to Section 5.1 and Section 8.3 of this Debenture, in whole or in part, the Indebtedness then outstanding into Common Shares at the Conversion Price and in accordance with the terms hereof, notwithstanding the limitation set forth in Section 6.1.

 

  16.
   

 

8.4Remedies Cumulative The rights and remedies of the Debentureholder hereunder are cumulative and in addition to and not in substitution for any rights or remedies provided by law.

 

8.5Non-Merger The taking of a judgment or judgments or any other action or dealing whatsoever by the Debentureholder in respect of any security given by the Corporation (if any) to the Debentureholder shall not operate as a merger of any indebtedness or liability of the Corporation to the Debentureholder or in any way suspend payment or affect or prejudice the rights, remedies and powers, legal or equitable, which the Debentureholder may have in connection with such liabilities and the surrender, cancellation or any other dealings with any security for such liabilities shall not release or affect the liability of the Corporation hereunder or any security held by the Debentureholder. All Obligations shall survive the Maturity Date until all Obligations of the Corporation hereunder have been satisfied and discharged in accordance with this Debenture.

 

9.Person Entitled to Payment

 

The Debentureholder shall be entitled to payment of all amounts due hereunder free from all equities or rights of set-off or counterclaim between the Corporation and the original or any intermediate Debentureholder hereof and all persons may act accordingly and a transferee of this Debenture shall become the Debentureholder of this Debenture free from all equities or rights of set-off or counterclaim between the Corporation and the transferor or any previous Debentureholder hereof, save in respect of equities of which the Corporation is required to take notice by statute or by order of a court of competent jurisdiction.

 

10.Supplement to Debenture

 

10.1From time to time the Corporation shall, when so directed by the Debentureholder, execute, acknowledge and deliver by its proper officers, deeds or instruments supplemental hereto, which thereafter shall form part hereof, for any one or more of the following purposes:

 

(a)making such provisions not inconsistent with this Debenture as may be necessary or desirable with respect to matters or questions arising hereunder, including the making of any modifications in the form of the Debenture which do not affect the substance thereof and which provisions and modifications will not, in the opinion of the Debentureholder’s solicitor, be prejudicial to the interests of the Debentureholder;

 

(b)evidencing the succession or the successive successions of other corporations to the Corporation and the covenants of and obligations assumed by any such successor in accordance with the provisions of this Debenture; and

 

(c)for any other purpose not inconsistent with the terms of this Debenture.

 

  17.
   

 

 

10.2The Corporation may correct any typographical or other manifest errors in this Debenture, provided that in the opinion of the Debentureholder’s solicitor such corrections will not prejudice the rights of the Debentureholder hereunder and may execute all such documents as may be necessary to correct such errors.

 

11.Mutilation, Loss, Theft or Destruction

 

In case this Debenture shall become mutilated or be lost, stolen or destroyed, the Corporation shall execute and deliver a new Debenture having the same date of issue upon surrender and cancellation of the mutilated Debenture, or in case this Debenture is lost, stolen or destroyed, in lieu of and in substitution for the same. In case of loss, theft or destruction the person applying for a substituted Debenture shall furnish to the Corporation such evidence of such loss, theft or destruction as shall be satisfactory to the Corporation, shall furnish an indemnity satisfactory to the Corporation (but in any event in an amount not exceeding the principal amount outstanding) and shall pay all reasonable expenses incidental to the issuance of any substituted Debenture.

 

12.Debentureholder Not a Shareholder

 

This Debenture shall, in itself, not confer or be construed as conferring upon the Debentureholder any right or interest whatsoever as a shareholder of the Corporation, including, but not limited to, the right to vote at, to receive notice of, or to attend meetings of shareholders or any other proceedings of the Corporation, or the right to receive dividends and other distributions.

 

13.Transfer of Debentures

 

13.1The Corporation shall maintain a register on which are recorded the names and addresses of each holder hereof. Subject to compliance with the terms of this Debenture and with applicable laws and regulations, a transfer shall be recorded by the Corporation in the register of holders hereof maintained by the Corporation, upon surrender of this Debenture with the Transfer Form in the form attached hereto as Schedule “B” duly completed by the Debentureholder or by its duly authorized attorney or representative, or accompanied by proper evidence of succession, assignment or other authority to transfer on behalf of the Debentureholder. Upon each transfer the Corporation shall cancel this Debenture and execute and deliver such replacement debenture as is required, in the form hereof.

 

13.2Restrictions on Transfers: The Corporation shall not register any transfers of the Debenture or issue or transfer any Common Shares issuable on conversion of the Debenture:

 

(a)to a United States person, any person in the United States or any person for the account or benefit of a United States person or a person in the United States except pursuant to Rule 144 under the United States Securities Act of 1993, as amended (the “U.S. Securities Act”), if available;

 

(b)in connection with any transfers or conversions which are otherwise not in compliance with (i) the U.S. Securities Act and the regulations thereunder if applicable, (ii) the Securities Act (Ontario) and the rules and regulations thereunder, (iii) applicable securities laws and regulations of other relevant jurisdictions, or (iv) the policies of the TSX Venture Exchange; and

 

  18.
   

 

(c)within four months and a day from the Closing Date, unless the Corporation and its legal counsel are satisfied, acting reasonably, that it is permitted under applicable Securities Laws and under the policies of the TSX Venture Exchange.

 

Notwithstanding anything to the contrary contained herein but subject to the terms of this Section 13, no assignment or transfer of any right or interest in this Debenture shall be permitted except upon the occurrence of an Event of Default, upon which the Debentureholder shall have the right to assign this Debenture without consent of the Corporation, and in compliance with applicable Securities Laws and the transferee, assignee or Debentureholder as the case may be, furnishes to the Corporation such evidence as the Corporation may reasonably require in order to satisfy itself with respect to the foregoing. No prior written consent of the Corporation is required to permit the assignment or transfer of any right or interest in this Debenture by a Debentureholder to any affiliate of the Debentureholder or to any investment fund managed by the Debentureholder’s manager or its affiliate provided the other conditions to such assignment or transfer as provided in this Section 13 are satisfied. Any purported assignment or transfer of any right or interest in this Debenture by a Debentureholder that is not in compliance with this Section 13 shall be null and void.

 

The appropriate legends, as follows, will be placed on the certificates representing the Common Shares issued on conversion of the Debenture denoting the restrictions on transfer imposed by applicable Securities Laws and the policies of the TSX Venture Exchange, including but not limited to the following legends:

 

“UNLESS PERMITTED UNDER SECURITIES LEGISLATION, THE HOLDER OF THIS SECURITY MUST NOT TRADE THE SECURITY BEFORE MARCH 17, 2021.”

 

“THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “U.S. SECURITIES ACT”) OR U.S. STATE SECURITIES LAWS. THESE SECURITIES MAY BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED, DIRECTLY OR INDIRECTLY, ONLY (A) TO BRIACELL THERAPEUTICS CORP. (THE “CORPORATION”), (B) OUTSIDE THE UNITED STATES IN COMPLIANCE WITH RULE 904 OF REGULATION S UNDER THE U.S. SECURITIES ACT AND IN COMPLIANCE WITH APPLICABLE LOCAL LAWS AND REGULATIONS, (C) IN COMPLIANCE WITH THE EXEMPTION FROM THE REGISTRATION REQUIREMENTS UNDER THE U.S. SECURITIES ACT PROVIDED BY (I) RULE 144 THEREUNDER IF AVAILABLE OR (II) RULE 144A THEREUNDER, IF AVAILABLE, AND IN EACH CASE IN ACCORDANCE WITH APPLICABLE U.S. STATE SECURITIES LAWS, (D) IN ANOTHER TRANSACTION THAT DOES NOT REQUIRE REGISTRATION UNDER THE U.S. SECURITIES ACT OR ANY APPLICABLE STATE SECURITIES LAWS, OR (E) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE U.S. SECURITIES ACT, PROVIDED THAT, IN THE CASE OF TRANSFERS PURSUANT TO (C)(I) OR (D) ABOVE, THE HOLDER HAS, PRIOR TO SUCH TRANSFER, FURNISHED TO THE CORPORATION AN OPINION OF COUNSEL OR OTHER EVIDENCE OF EXEMPTION, IN EITHER CASE REASONABLY SATISFACTORY TO THE CORPORATION. DELIVERY OF THIS CERTIFICATE MAY NOT CONSTITUTE “GOOD DELIVERY” IN SETTLEMENT OF TRANSACTIONS ON STOCK EXCHANGES IN CANADA.”

 

  19.
   

 

and if required:

 

“WITHOUT PRIOR WRITTEN APPROVAL OF THE TSX VENTURE EXCHANGE AND COMPLIANCE WITH ALL APPLICABLE SECURITIES LEGISLATION, THE SECURITIES REPRESENTED BY THIS CERTIFICATE MAY NOT BE SOLD, TRANSFERRED, HYPOTHECATED OR OTHERWISE TRADED ON OR THROUGH THE FACILITIES OF THE TSX VENTURE EXCHANGE OR OTHERWISE IN CANADA OR TO OR FOR THE BENEFIT OF A CANADIAN RESIDENT MARCH 17, 2021.”

 

14.Certain Requirements re: Successor Corporations

 

The Corporation shall not, directly or indirectly, sell, lease, transfer or otherwise dispose of all or substantially all of its property and assets as an entirety to any other entity, and shall not consolidate, amalgamate, reorganize or merge with or into any other corporation (any such other entity or corporation being herein referred to as a “successor corporation”) unless:

 

(a)the successor corporation shall execute, prior to or contemporaneously with the consummation of any such transaction, such instruments as are reasonably necessary to evidence the assumption by the successor corporation of the due and punctual payment of the outstanding amount of this Debenture or the reservation and allotment for issuance of a sufficient number of common shares of the successor corporation to satisfy the conversion privilege and interest payment obligations hereunder and to observe and perform all the covenants and obligations of the Corporation under this Debenture and the Subscription Agreement;

 

(b)such transaction shall be upon such terms as to preserve and not to impair any of the rights or powers of the Debentureholder hereunder, under the Subscription Agreement or any security pertaining hereto or thereto; and

 

(c)immediately after giving effect to such transaction, no condition or event shall exist which constitutes an Event of Default, or may constitute an Event of Default after notice or lapse of time or both.

 

  20.
   

 

15.Vesting of Powers in Successors

 

Whenever the conditions of Section 14 have been fully observed and performed, the successor corporation shall possess and from time to time may exercise each and every right and power of the Corporation under this Debenture in the name of the Corporation or otherwise and any act or proceeding by any provision of this Debenture required to be done or performed by the Corporation or its officers may be done and performed with like force and effect by the successor corporation or its officers.

 

16.Waiver

 

No waiver on the part of the Debentureholder in exercising any right or privilege hereunder and no waiver as to any Event of Default hereunder shall operate as a waiver thereof unless made in writing and signed by the Debentureholder. No written waiver shall preclude the further or other exercise by the Debentureholder of any right, power or privilege hereunder, or extend to or apply to any further Event of Default.

 

17.Further Assurances

 

The Corporation shall from time to time forthwith on the Debentureholder’s request do, make and execute all such further assignments, documents, acts, matters and things as may be required by the Debentureholder with respect to give effect to the matters contemplated in the Credit Documents or any part thereof, including all matters contemplated in this Debenture.

 

18.Notices

 

Any notice or communication to be given hereunder may be effectively given by delivering the same at the addresses hereinafter set forth or by sending the same by email or prepaid registered mail to the parties at such addresses. Any notice so mailed shall be deemed to have been received on the fifth (5th) Business Day next following the mailing thereof provided the postal service is in operation during such time. Any email notice shall be deemed to have been received on the Business Day next following the date of transmission. The mailing and email addresses of the parties for the purposes hereof shall respectively be:

 

if to the Debentureholder: To the address set out on the face page, with a copy to:

 

  Garfinkle Biderman LLP
  1 Adelaide Street East, Suite 801
  Toronto, Ontario M5C 1J4
   
  Attention: Shimmy Posen
  Email: sposen@garfinkle.com
   
if to the Corporation: BriaCell Therapeutics Corp.
   
  3rd Floor, Bellevue Centre, 235-15th Street
  West Vancouver, British Columbia V7T 2X1
   
  Attention: Jamieson Bondarenko
  Email: jbondarenko@briacell.com

 

  21.
   

 

Either party may from time to time notify the other party hereto, in accordance with the provisions hereof, of any change of address which thereafter, until changed by like notice, shall be the address of such party for all purposes of this Agreement.

 

19.Successors and Assigns

 

This Debenture shall be binding upon and shall enure to the benefit of the Corporation and the Debentureholder and their respective successors and assigns, provided that neither party shall assign any of its rights or obligations hereunder without the prior written consent of the other party, which consent shall not be unreasonably withheld.

 

20.Governing Law and Submission to Jurisdiction

 

This Debenture and all other documents delivered to the Debentureholder hereunder shall be construed and interpreted in accordance with the laws of the Province of Ontario and the federal laws of Canada applicable therein. Each of the Corporation and the Debentureholder hereby agrees that any legal suit, action or proceeding arising out of or relating to this Debenture and all such other documents may be instituted in the courts of the Province of Ontario only and the parties accept and irrevocably submit to the jurisdiction of the said courts, and acknowledge their competence and agree to be bound by any judgment thereof.

 

21.The Debentureholder agrees that it shall be prohibited from exercising any portion of this Debenture if the aggregate number of Common Shares of the Corporation owned or controlled, directly or indirectly, by the Debentureholder and any affiliates of the Debentureholder (including common shares of which the Debentureholder has deemed beneficial ownership), collectively, as a result of such exercise would equal or exceed 4.99% of the issued and outstanding common shares of the Corporation calculated on the date of exercise of the Debenture.

 

[remainder of page intentionally left blank]

 

  22.
   

 

DATED as of the ____ day of November, 2020.

 

  BRIACELL THERAPEUTICS CORP.
   
By:                                
    Authorized Signatory

 

Signature Page Debenture

 

  
   

 

SCHEDULE “A”

 

CONVERSION NOTICE

 

TO: BRIACELL THERAPEUTICS CORP.

 

Reference is made to the Unsecured Convertible Debenture of BriaCell Therapeutics Corp. dated November 16, 2020. Any term not otherwise defined in this Notice shall have the meaning ascribed to it in the Debenture.

 

The undersigned Debentureholder of the Debenture hereby gives notice that it elects to convert certain Indebtedness for the undernoted number of Common Shares in accordance with the terms of the Debenture and as follows.

 

Amount of Indebtedness Being Converted: $_____________________
   
Common Shares to be Issued: ______________________
   
Effective Date: ______________________
   

The undersigned hereby directs that the shares are to be issued and delivered as follows:

 

Registration Instructions:   Delivery Instructions:
     
     

 

Any unpaid interest shall be paid by cash

 

Dated this ______day ______________, 20______.

 

  EVERGREEN CAPITAL MANAGEMENT LLC
   
  Per:                        
    Name:
    Title:
    (authorized signing officer)

 

Instructions for Conversion

 

This conversion notice is to be signed by the Debentureholder.

 

The Debenture must be surrendered at the office of the Corporation, located at 3rd Floor, Bellevue Centre, 235-15th Street West Vancouver, British Columbia V7T 2X1

 

Fractional Common Shares will not be issued on any conversion and if any fractional Common Shares would be delivered upon conversion of any amount hereunder, the number of Common Shares to be issued shall be rounded down to the nearest whole Common Share.

 

Upon surrender of the Debenture, the Corporation will issue to the Debentureholder the number of shares converted and shall deliver a certificate(s) or other evidence of such shares. The Corporation shall also deliver a new debenture in the event of a partial conversion.

 

If Common Shares are to be issued in the name of a person other than the Debentureholder, all requisite transfer taxes must be tendered by the Debentureholder.

 

 2.
   

 

SCHEDULE “B”
TRANSFER FORM

 

TO:BRIACELL THERAPEUTICS CORP.

 

FOR VALUE RECEIVED, the undersigned hereby sells, assigns and transfers unto:

 

 
Name
 
Address
 
Social Insurance Number, Social Security Number, or Tax Identification Number

 

$______________ of the principal amount of Debenture registered in the name of the undersigned represented by the within certificate (which amount must be $1,000 or an integral multiple thereof) and do hereby irrevocably constitute and appoint the Corporate Secretary of the Corporation attorney to transfer the said Debenture on the books of the Corporation with full power of substitution in the premises.

 

DATED this _________ day of ____.

 

                                          
    Signature of Debentureholder
     
    Name of Debentureholder (Please Print)
     
    Authorized Signature Name and Title

 

   

EX-4.5 4 ex4-5.htm

 

Exhibit 4.5

 

UNLESS PERMITTED UNDER SECURITIES LEGISLATION, THE HOLDER OF THIS SECURITY MUST NOT TRADE THE SECURITY BEFORE MARCH 17, 2021.

 

THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “U.S. SECURITIES ACT”) OR U.S. STATE SECURITIES LAWS. THESE SECURITIES MAY BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED, DIRECTLY OR INDIRECTLY, ONLY (A) TO BRIACELL THERAPEUTICS CORP. (THE “CORPORATION”), (B) OUTSIDE THE UNITED STATES IN COMPLIANCE WITH RULE 904 OF REGULATION S UNDER THE U.S. SECURITIES ACT AND IN COMPLIANCE WITH APPLICABLE LOCAL LAWS AND REGULATIONS, (C) IN COMPLIANCE WITH THE EXEMPTION FROM THE REGISTRATION REQUIREMENTS UNDER THE U.S. SECURITIES ACT PROVIDED BY (I) RULE 144 THEREUNDER IF AVAILABLE OR (II) RULE 144A THEREUNDER, IF AVAILABLE, AND IN EACH CASE IN ACCORDANCE WITH APPLICABLE U.S. STATE SECURITIES LAWS, (D) IN ANOTHER TRANSACTION THAT DOES NOT REQUIRE REGISTRATION UNDER THE U.S. SECURITIES ACT OR ANY APPLICABLE STATE SECURITIES LAWS, OR (E) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE U.S. SECURITIES ACT, PROVIDED THAT, IN THE CASE OF TRANSFERS PURSUANT TO (C)(I) OR (D) ABOVE, THE HOLDER HAS, PRIOR TO SUCH TRANSFER, FURNISHED TO THE CORPORATION AN OPINION OF COUNSEL OR OTHER EVIDENCE OF EXEMPTION, IN EITHER CASE REASONABLY SATISFACTORY TO THE CORPORATION. DELIVERY OF THIS CERTIFICATE MAY NOT CONSTITUTE “GOOD DELIVERY” IN SETTLEMENT OF TRANSACTIONS ON STOCK EXCHANGES IN CANADA.

 

WARRANTS TO PURCHASE
COMMON SHARES OF BRIACELL THERAPEUTICS CORP.

 

Warrant Certificate Number:

 

2020 November — 001

Number of Warrants:

 

69,188

 

THIS IS TO CERTIFY THAT for value received, Evergreen Capital Management LLC, 156 W Saddle River Road, Saddle River, NJ 07458 (the “Warrantholder”) has the right to purchase in respect of each whole warrant (individually a “Warrant” and collectively the “Warrants”) represented by this certificate or by a replacement certificate (in either case this “Warrant Certificate”), one (1) fully paid and non-assessable common share (individually, a “Common Share” and collectively, the “Common Shares” and which terms shall include any shares or other securities to be issued in addition thereto or in substitution or replacement therefor as provided herein) of BriaCell Therapeutics Corp. (the “Corporation”), a corporation existing under the Business Corporations Act (British Columbia), as constituted on the date hereof, at a purchase price (the purchase price in effect from time to time being called the “Exercise Price”) of $5.42 per Common Share, subject to adjustment as provided herein, at any time up to 5:00 p.m. Toronto time (the “Expiry Time”) on November 16, 2025 (the “Expiry Date”).

 

The Corporation agrees that the Common Shares purchased pursuant to the exercise of the Warrants shall be and be deemed to be issued to the Warrantholder as of the close of business on the date on which this Warrant Certificate shall have been surrendered and payment made for such Common Shares as aforesaid.

Nothing contained herein shall confer any right upon the Warrantholder to subscribe for or purchase any Common Shares at any time after the Expiry Time and from and after the Expiry Time the Warrants and all rights under this Warrant Certificate shall be void and of no value.

 

   
   

 

The above provisions are subject to the following:

 

1.Exercise:

 

(1)Cash Exercise: In the event that the Warrantholder desires to exercise the right to purchase Common Shares conferred hereby, the Warrantholder shall (a) complete to the extent possible in the manner indicated, and execute a subscription form substantially in the form attached as Schedule A to this Warrant Certificate, (b) surrender this Warrant Certificate to the Corporation in accordance with Section 9 of this Warrant Certificate, and (c) pay the amount payable upon the exercise of such Warrants in respect of the Common Shares subscribed for by certified cheque, bank draft or money order in lawful money of Canada payable to the Corporation or by transmitting same day funds in lawful money of Canada by wire to such account as the Corporation shall direct the Warrantholder or indicate that the exercise is a cashless exercise as provided in subsection 1(2) hereof. Upon such surrender and payment as aforesaid, the Warrantholder shall be deemed for all purposes to be the holder of record of the number of Common Shares to be so issued and the Warrantholder shall be entitled to delivery of a certificate or certificates representing such Common Shares and the Corporation shall cause such certificate or certificates to be delivered to the Warrantholder at the address specified in the subscription form within three business days after such surrender and payment as aforesaid. No fractional Common Shares will be issuable upon any exercise of the Warrants and the Warrantholder will not be entitled to any cash payment or compensation in lieu of a fractional Common Share.

 

(2)Cashless Exercise: Subject to the provisions of this Warrant Certificate other than those requiring payment of the Exercise Price in cash, the Warrantholder may elect to exercise this Warrant in whole by surrendering this Warrant Certificate in the manner specified in subsection 1(1) hereof by means of a “cashless exercise” in which the Warrantholder shall be entitled to receive a certificate representing the number of Common Shares equal to the quotient obtained by dividing [(A-B) (X)] by (A), where:

 

A = the volume weighted average trading price of the Common Shares on the TSX Venture Exchange or if the Common Shares are not then listed on the TSX Venture Exchange, on such other Canadian stock exchange as may be selected by the directors of the Corporation for such purpose or, if the Common Shares are not then listed on any Canadian stock exchange, in the over-the-counter market, for the one (1) day period ending on the trading day immediately preceding the date on which Warrantholder elects to exercise this Warrant Certificate by means of a “cashless exercise,” as set forth in the applicable subscription form substantially in the form attached as Schedule A;

 

B = the Exercise Price of this Warrant Certificate, as adjusted hereunder; and

 

X = the number of Common Shares that would be issuable upon exercise of this Warrant Certificate in accordance with the terms of this Warrant Certificate if such exercise were by means of a cash exercise rather than a cashless exercise.

 

   
   

 

2.Partial Exercise: The Warrantholder may from time to time subscribe for and purchase any lesser number of Common Shares than the number of Common Shares expressed in this Warrant Certificate. In the event that the Warrantholder subscribes for and purchases any such lesser number of Common Shares prior to the Expiry Time on the Expiry Date, the Warrantholder shall be entitled to receive a replacement certificate representing the unexercised balance of the Warrants.

 

3.Not a Shareholder: The holding of the Warrants shall not constitute the Warrantholder a shareholder of the Corporation nor entitle the Warrantholder to any right or interest in respect thereof except as expressly provided in this Warrant Certificate.

 

4.Covenants, Representations and Warranties: The Corporation hereby represents and warrants that it is authorized to create and issue the Warrants and covenants and agrees that it will cause the Common Shares from time to time subscribed for and purchased in the manner provided in this Warrant Certificate and the certificate or certificates representing such Common Shares to be issued and that, at all times prior to the Expiry Time, it will reserve and there will remain unissued a sufficient number of Common Shares to satisfy the right of purchase provided for in this Warrant Certificate. The Corporation hereby further covenants and agrees that it will, at its expense, expeditiously use its best efforts to obtain the listing of such Common Shares (subject to issue or notice of issue) on each stock exchange or over-the-counter market on which the Common Shares are listed at the relevant time. All Common Shares which are issued upon the exercise of the right of purchase provided in this Warrant Certificate, upon payment therefor of the amount at which such Common Shares may be purchased pursuant to the provisions of this Warrant Certificate, shall be deemed to be fully paid and non-assessable shares and free from all taxes, liens and charges with respect to the issue thereof. The Corporation hereby represents and warrants that this Warrant Certificate is a valid and enforceable obligation of the Corporation, enforceable in accordance with the provisions of this Warrant Certificate.

 

5.Anti-Dilution Protection:

 

(1)Definitions: For the purposes of this section 5, unless there is something in the subject matter or context inconsistent therewith, the words and terms defined below shall have the respective meanings specified therefor in this subsection 5(1):

 

(a)Adjustment Period” means the period commencing on the date of issue of the Warrants and ending at the Expiry Time on the Expiry Date;

 

(b)Current Market Price” of the Common Shares at any date means the price per share equal to the weighted average price at which the Common Shares have traded on the TSX Venture Exchange or, if the Common Shares are not then listed on the TSX Venture Exchange, on such other Canadian stock exchange as may be selected by the directors of the Corporation for such purpose or, if the Common Shares are not then listed on any Canadian stock exchange, in the over-the-counter market, during the period of any ten (10) consecutive trading days ending on the third business day before such date; provided that the weighted average price shall be determined by dividing the aggregate sale price of all Common Shares sold on the said exchange or market, as the case may be, during such ten (10) consecutive trading days by the total number of Common Shares so sold; and provided further that if the Common Shares are not then listed on any Canadian stock exchange or traded in the over-the-counter market, then the Current Market Price shall be determined by a firm of independent chartered accountants selected by the directors of the Corporation;

 

   
   

 

 

(c)director” or “director of the Corporation” means a director of the Corporation at the relevant time and, unless otherwise specified herein, a reference to action “by the directors” means action by the directors of the Corporation as a board or, whenever empowered, action by any committee of the directors of the Corporation; and

 

(d)trading day” with respect to a stock exchange or over-the-counter market means a day on which such stock exchange or market is open for business.

 

(2)Adjustments: The Exercise Price and the number of Common Shares issuable to the Warrantholder pursuant to this Warrant Certificate shall be subject to adjustment from time to time in the events and in the manner provided as follows:

 

(a)If at any time during the Adjustment Period the Corporation shall:

 

(i)fix a record date for the issue of, or issue, Common Shares to the holders of all or substantially all of the outstanding Common Shares by way of a stock dividend;
   
(ii)fix a record date for the distribution to, or make a distribution to, the holders of all or substantially all of the outstanding Common Shares payable in Common Shares or securities exchangeable or exercisable for or convertible into Common Shares;
   
(iii)subdivide the outstanding Common Shares into a greater number of Common Shares; or
   
(iv)consolidate the outstanding Common Shares into a lesser number of Common Shares;

 

(any of such events in subclauses 5(2)(a)(i), 5(2)(a)(ii), 5(2)(a)(iii) and 5(2)(a)(iv) above being herein called a “Common Share Reorganization”), the Exercise Price shall be adjusted on the earlier of the record date on which holders of Common Shares are determined for the purposes of the Common Share Reorganization and the effective date of the Common Share Reorganization to the amount determined by multiplying the Exercise Price in effect immediately prior to such record date or effective date, as the case may be, by a fraction:

 

A.the numerator of which shall be the number of Common Shares outstanding on such record date or effective date, as the case may be, before giving effect to such Common Share Reorganization; and

 

B.the denominator of which shall be the number of Common Shares which will be outstanding immediately after giving effect to such Common Share Reorganization (including, in the case of a distribution of securities exchangeable or exercisable for or convertible into Common Shares, the number of Common Shares that would be outstanding had such securities all been exchanged or exercised for or converted into Common Shares on such date).

 

   
   

 

To the extent that any adjustment in the Exercise Price occurs pursuant to this clause 5(2)(a) as a result of the fixing by the Corporation of a record date for the distribution of securities exchangeable or exercisable for or convertible into Common Shares, the Exercise Price shall be readjusted immediately after the expiry of any relevant exchange, exercise or conversion right to the Exercise Price which would then be in effect based upon the number of Common Shares actually issued and remaining issuable after such expiry and shall be further readjusted in such manner upon the expiry of any further such right. Any Warrantholder who has not exercised it’s right to subscribe for and purchase Common Shares on or prior to the record date of such stock dividend or distribution or the effective date of such subdivision or consolidation, as the case may be, upon the exercise of such right thereafter shall be entitled to receive and shall accept in lieu of the number of Common Shares then subscribed for and purchased by such Warrantholder, at the Exercise Price determined in accordance with this clause 5(2)(a), the aggregate number of Common Shares that such Warrantholder would have been entitled to receive as a result of such Common Share Reorganization, if, on such record date or effective date, as the case may be, such Warrantholder had been the holder of record of the number of Common Shares so subscribed for and purchased.

 

(b)If, at any time during the Adjustment Period, the Corporation shall fix a record date for the issue or distribution to the holders of all or substantially all of the outstanding Common Shares of rights, options or warrants pursuant to which such holders are entitled, during a period expiring not more than 45 days after the record date for such issue (such period being the “Rights Period”), to subscribe for or purchase Common Shares or securities exchangeable or exercisable for or convertible into Common Shares at a price per share to the holder (or, in the case of securities exchangeable or exercisable for or convertible into Common Shares, at an exchange, exercise or conversion price per share) at the date of issue of such securities of less than 95% of the Current Market Price of the Common Shares on such record date (any of such events being called a “Rights Offering”), the Exercise Price shall be adjusted effective immediately after the record date for such Rights Offering to the amount determined by multiplying the Exercise Price in effect on such record date by a fraction:

 

(i)the numerator of which shall be the aggregate of

 

A.the number of Common Shares outstanding on the record date for the Rights Offering, and

 

B.the quotient determined by dividing

 

(1)either (a) the product of the number of Common Shares offered during the Rights Period pursuant to the Rights Offering and the price at which such Common Shares are offered, or, (b) the product of the exchange, exercise or conversion price of the securities so offered and the number of Common Shares for or into which the securities offered pursuant to the Rights Offering may be exchanged, exercised or converted, as the case may be, by
   
   

 

(2)the Current Market Price of the Common Shares as of the record date for the Rights Offering; and
   
(ii)the denominator of which shall be the aggregate of the number of Common Shares outstanding on such record date and the number of Common Shares offered pursuant to the Rights Offering (including, in the case of the issue or distribution of securities exchangeable or exercisable for or convertible into Common Shares, the number of Common Shares for or into which such securities may be exchanged, exercised or converted).

 

If, by the terms of the rights, options or warrants referred to in this clause 5(2)(b), there is more than one purchase, exchange, exercise or conversion price per Common Share, the aggregate price of the total number of additional Common Shares offered for subscription or purchase, or the aggregate exchange, exercise or conversion price of the exchangeable, exercisable or convertible securities so offered, shall be calculated for purposes of the adjustment on the basis of the lowest purchase, exchange, exercise or conversion price per Common Share, as the case may be. Any Common Shares owned by or held for the account of the Corporation shall be deemed not to be outstanding for the purpose of any such calculation. To the extent that any adjustment in the Exercise Price occurs pursuant to this clause 5(2)(b) as a result of the fixing by the Corporation of a record date for the issue or distribution of rights, options or warrants referred to in this clause 5(2)(b), the Exercise Price shall be readjusted immediately after the expiry of any relevant exchange, exercise or conversion right to the Exercise Price which would then be in effect based upon the number of Common Shares actually issued and remaining issuable after such expiry and shall be further readjusted in such manner upon the expiry of any further such right.

 

(c)If, at any time during the Adjustment Period, the Corporation shall fix a record date for the issue or distribution to the holders of all or substantially all of the outstanding Common Shares of:

 

(i)shares of the Corporation of any class other than Common Shares;

 

(ii)rights, options or warrants to acquire Common Shares or securities exchangeable or exercisable for or convertible into Common Shares or property or other assets of the Corporation (other than rights, options or warrants pursuant to which holders of Common Shares are entitled, during a period expiring not more than 45 days after the record date for such issue, to subscribe for or purchase Common Shares or securities exchangeable or exercisable for or convertible into Common Shares at a price per share (or in the case of securities exchangeable or exercisable for or convertible into Common Shares, at an exchange, exercise or conversion price per share) of at least 95% of the Current Market Price of the Common Shares on such record date);

 

(iii)evidences of indebtedness of the Corporation; or

 

(iv)any property or assets of the Corporation;
   
   

 

and if such issue or distribution does not constitute a Common Share Reorganization or a Rights Offering (any of such non-excluded events being herein called a “Special Distribution”), the Exercise Price shall be adjusted effective immediately after the record date for the Special Distribution to the amount determined by multiplying the Exercise Price in effect on the record date for the Special Distribution by a fraction:

 

A.the numerator of which shall be the difference between

 

(1)the product of the number of Common Shares outstanding on such record date and the Current Market Price of the Common Shares on such record date, and

 

(2)the fair market value, as determined by the directors of the Corporation, acting reasonably and in good faith, to the holders of Common Shares of the shares, rights, options, warrants, evidences of indebtedness or property or assets to be issued or distributed in the Special Distribution, and

 

B.the denominator of which shall be the product obtained by multiplying the number of Common Shares outstanding on such record date by the Current Market Price of the Common Shares on such record date.

 

Any Common Shares owned by or held for the account of the Corporation shall be deemed not to be outstanding for the purpose of such calculation. To the extent that any adjustment in the Exercise Price occurs pursuant to this clause 5(2)(c) as a result of the fixing by the Corporation of a record date for the issue or distribution of rights, options or warrants to acquire Common Shares or securities exchangeable or exercisable for or convertible into Common Shares referred to in this clause 5(2)(c), the Exercise Price shall be readjusted immediately after the expiry of any relevant exchange, exercise or conversion right to the amount which would then be in effect based upon the number of Common Shares issued and remaining issuable after such expiry and shall be further readjusted in such manner upon the expiry of any further such right.

 

(d)If, at any time during the Adjustment Period, there shall occur:

 

(i)a reclassification or redesignation of the Common Shares, a change of the Common Shares into other shares or securities or any other capital reorganization involving the Common Shares other than a Common Share Reorganization;

 

(ii)a consolidation, amalgamation, arrangement or merger of the Corporation with or into another body corporate which results in a reclassification or redesignation of the Common Shares or a change of the Common Shares into other shares or securities; or

 

   
   

 

(iii)the transfer of the undertaking or assets of the Corporation as an entirety or substantially as an entirety to another corporation or entity;

 

(any of such events being called a “Capital Reorganization”), after the effective date of the Capital Reorganization the Warrantholder shall be entitled to receive, and shall accept, for the same aggregate consideration, upon exercise of the Warrants, in lieu of the number of Common Shares to which the Warrantholder was theretofore entitled upon the exercise of the Warrants, the kind and aggregate number of shares and other securities or property resulting from the Capital Reorganization which the Warrantholder would have been entitled to receive as a result of the Capital Reorganization if, on the effective date thereof, the Warrantholder had been the registered holder of the number of Common Shares which the Warrantholder was theretofore entitled to purchase or receive upon the exercise of the Warrants. If necessary, as a result of any such Capital Reorganization, appropriate adjustments shall be made in the application of the provisions of this Warrant Certificate with respect to the rights and interests thereafter of the Warrantholder to the end that the provisions of this Warrant Certificate shall thereafter correspondingly be made applicable as nearly as may reasonably be possible in relation to any shares or other securities or property thereafter deliverable upon the exercise of the Warrants.

 

(e)If at any time during the Adjustment Period any adjustment or readjustment in the Exercise Price shall occur pursuant to the provisions of clause 5(2)(a), 5(2)(b) or 5(2)(c) of this Warrant Certificate, then the number of Common Shares purchasable upon the subsequent exercise of the Warrants shall be simultaneously adjusted or readjusted, as the case may be, by multiplying the number of Common Shares purchasable upon the exercise of the Warrants immediately prior to such adjustment or readjustment by a fraction which shall be the reciprocal of the fraction used in the adjustment or readjustment of the Exercise Price.

 

(3)Rules: The following rules and procedures shall be applicable to adjustments made pursuant to subsection 5(2) of this Warrant Certificate:

 

(a)Subject to the following clauses of this subsection 5(3), any adjustment made pursuant to subsection 5(2) hereof shall be cumulative and shall be made successively whenever an event referred to therein shall occur.

 

(b)No adjustment in the Exercise Price shall be required unless such adjustment would result in a change of at least one per cent in the then Exercise Price and no adjustment shall be made in the number of Common Shares purchasable upon the exercise of the Warrants unless it would result in a change of at least one one-hundredth of a Common Share; provided, however, that any adjustments which except for the provision of this clause 5(3)(b) would otherwise have been required to be made shall be carried forward and taken into account in any subsequent adjustment. Notwithstanding any other provision of subsection 5(2) hereof, no adjustment of the Exercise Price shall be made which would result in an increase in the Exercise Price or a decrease in the number of Common Shares issuable upon the exercise of the Warrants (except in respect of the Common Share Reorganization described in subclause 5(2)(a)(iv) hereof or a Capital Reorganization described in subclause 5(2)(d)(ii) hereof).

  

   
   

 

(c)No adjustment in the Exercise Price or in the number or kind of securities purchasable upon the exercise of the Warrants shall be made in respect of any event described in section 5 hereof if the Warrantholder is entitled to participate in such event on the same terms mutatis mutandis as if the Warrantholder had exercised the Warrants prior to or on the record date or effective date, as the case may be, of such event.

 

(d)No adjustment in the Exercise Price or in the number of Common Shares purchasable upon the exercise of the Warrants shall be made pursuant to subsection 5(2) hereof in respect of the issue from time to time of Common Shares pursuant to this Warrant Certificate or pursuant to any stock option, stock purchase or stock bonus plan in effect from time to time for directors, officers or employees of the Corporation and/or any subsidiary of the Corporation and any such issue, and any grant of options in connection therewith, shall be deemed not to be a Common Share Reorganization, a Rights Offering nor any other event described in subsection 5(2) hereof.

 

(e)If, at any time during the Adjustment Period, the Corporation shall take any action affecting the Common Shares, other than an action or event described in subsection 5(2) hereof, which, in the opinion of the directors of the Corporation, acting reasonably and in good faith, would have a material adverse effect upon the rights of Warrantholders, either or both the Exercise Price and the number of Common Shares purchasable upon exercise of the Warrants shall be adjusted in such manner and at such time by action by the directors of the Corporation, in their sole discretion, acting reasonably and in good faith, but subject to the prior written consent of the TSX Venture Exchange, as may be equitable in the circumstances. Failure of the taking of action by the directors of the Corporation so as to provide for an adjustment prior to the effective date of any action by the Corporation affecting the Common Shares shall be deemed to be conclusive evidence that the directors of the Corporation have determined that it is equitable to make no adjustment in the circumstances.

 

(f)If the Corporation shall set a record date to determine holders of Common Shares for the purpose of entitling such holders to receive any dividend or distribution or any subscription or purchase rights and shall, thereafter and before the distribution to such holders of any such dividend, distribution or subscription or purchase rights, legally abandon its plan to pay or deliver such dividend, distribution or subscription or purchase rights, then no adjustment in the Exercise Price or the number of Common Shares purchasable upon the exercise of the Warrants shall be required by reason of the setting of such record date.

 

(g)In any case in which this Warrant Certificate shall require that an adjustment shall become effective immediately after a record date for an event referred to in subsection 5(2) hereof, the Corporation may defer, until the occurrence of such event:

 

(i)issuing to the Warrantholder, to the extent that the Warrants are exercised after such record date and before the occurrence of such event, the additional Common Shares or other securities issuable upon such exercise by reason of the adjustment required by such event; and
   
   

 

(ii)delivering to the Warrantholder any distribution declared with respect to such additional Common Shares or other securities after such record date and before such event;

 

provided, however, that the Corporation shall deliver to the Warrantholder an appropriate instrument evidencing the right of the Warrantholder upon the occurrence of the event requiring the adjustment, to an adjustment in the Exercise Price and/or the number of Common Shares purchasable upon the exercise of the Warrants and to such distribution declared with respect to any such additional Common Shares issuable upon the exercise of the Warrants.

 

(h)In the absence of a resolution of the directors of the Corporation fixing a record date for a Rights Offering, the Corporation shall be deemed to have fixed as the record date therefor the date of the issue of the rights, options or warrants issued pursuant to the Rights Offering.

 

(i)If a dispute shall at any time arise with respect to adjustments of the Exercise Price or the number of Common Shares purchasable upon the exercise of the Warrants, such disputes shall be conclusively determined by the auditors of the Corporation or if they are unable or unwilling to act, by such other firm of independent chartered accountants as may be selected by the directors of the Corporation and any such determination shall be conclusive evidence of the correctness of any adjustment made pursuant to subsection 5(2) hereof and shall be binding upon the Corporation and the Warrantholder.

 

(j)As a condition precedent to the taking of any action which would require an adjustment pursuant to subsection 5(2) hereof, including the Exercise Price and the number or class of Common Shares or other securities which are to be received upon the exercise thereof, the Corporation shall take any action which may, in the opinion of counsel to the Corporation, be necessary in order that the Corporation may validly and legally issue as fully paid and non-assessable shares all of the Common Shares or other securities which the Warrantholder is entitled to receive in accordance with the provisions of this Warrant Certificate.

 

(4)Notice: At least twenty-one (21) days prior to the earlier of the record date or effective date of any event which requires or might require an adjustment in any of the rights of the Warrantholder under this Warrant Certificate, including the Exercise Price or the number of Common Shares which may be purchased under this Warrant Certificate, the Corporation shall deliver to the Warrantholder a certificate of the Corporation specifying the particulars of such event and, if determinable, the required adjustment and the calculation of such adjustment. In case any adjustment for which a notice in this subsection 5(4) has been given is not then determinable, the Corporation shall promptly after such adjustment is determinable deliver to the Warrantholder a certificate providing the calculation of such adjustment. The Corporation hereby covenants and agrees that the register of transfers and share transfer books for the Common Shares will be open, and that the Corporation will not take any action which might deprive the Warrantholder of the opportunity of exercising the rights of subscription contained in this Warrant Certificate, during such 21 day period.

 

   
   

 

6.Further Assurances: The Corporation hereby covenants and agrees that it will do, execute, acknowledge and deliver, or cause to be done, executed, acknowledged and delivered, all and every such other act, deed and assurance as the Warrantholder shall reasonably require for the better accomplishing and effectuating of the intentions and provisions of this Warrant Certificate.

 

7.Time of Essence: Time shall be of the essence of this Warrant Certificate.

 

8.Governing Laws: This Warrant Certificate shall be construed in accordance with the laws of the Province of Ontario and the federal laws of Canada applicable therein.

 

9.Notices: All notices or other communications to be given under this Warrant Certificate shall be delivered by hand, by facsimile or by emailed portable document format (“PDF”) and, if delivered by hand, shall be deemed to have been given on the delivery date and, if sent by facsimile or emailed PDF, on the date of transmission if sent before 5:00 p.m., Toronto time, on a business day or, if sent after 5:00 p.m., Toronto time, or such day is not a business day, on the first business day following the date of transmission.

 

Notices to the Corporation shall be addressed to:

 

BriaCell Therapeutics Corp.

3rd Floor, Bellevue Centre

235-15th Street
West Vancouver, British Columbia V7T 2X1

 

Attention: Jamieson Bondarenko

Email: jbondarenko@briacell.com

 

with a copy (which shall not constitute notice) to:

 

Bennett Jones LLP

3400 One First Canadian Place

P.O. Box 130

Toronto, ON M5X 1A4

 

Attention: Aaron Sonshine

Email: SonshineA@bennettjones.com

 

Notices to the Warrantholder shall be addressed to the address of the Warrantholder set out on the face page of this Warrant Certificate.

 

The Corporation or the Warrantholder may change its address for service by notice in writing to the other of them specifying its new address for service under this Warrant Certificate.

 

10.Legends on Common Shares: Any certificate representing Common Shares issued upon the exercise of the Warrants prior to the date which is four months and one day after the date hereof will bear the following legends:

 

“UNLESS PERMITTED UNDER SECURITIES LEGISLATION, THE HOLDER OF THIS SECURITY MUST NOT TRADE THE SECURITY BEFORE MARCH 17, 2021.”

  

   
   

 

and if required:

 

“WITHOUT PRIOR WRITTEN APPROVAL OF THE TSX VENTURE EXCHANGE AND COMPLIANCE WITH ALL APPLICABLE SECURITIES LEGISLATION, THE SECURITIES REPRESENTED BY THIS CERTIFICATE MAY NOT BE SOLD, TRANSFERRED, HYPOTHECATED OR OTHERWISE TRADED ON OR THROUGH THE FACILITIES OF THE TSX VENTURE EXCHANGE OR OTHERWISE IN CANADA OR TO OR FOR THE BENEFIT OF A CANADIAN RESIDENT MARCH 17, 2021.”;

 

provided that at any time subsequent to the date which is four months and one day after the date hereof any certificate representing such Common Shares may be exchanged for a certificate or certificates bearing no such legends. The Corporation hereby covenants and agrees that it will use the best efforts thereof to deliver or to cause to be delivered a certificate or certificates representing such Common Shares bearing no such legends within three business days after receipt of the legended certificate or certificates.

 

11.United States Restrictions on Exercise and Resale: Any certificate representing Common Shares issued upon the exercise of the Warrants will bear the following legend:

 

“THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “U.S. SECURITIES ACT”) OR U.S. STATE SECURITIES LAWS. THESE SECURITIES MAY BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED, DIRECTLY OR INDIRECTLY, ONLY (A) TO BRIACELL THERAPEUTICS CORP. (THE “CORPORATION”), (B) OUTSIDE THE UNITED STATES IN COMPLIANCE WITH RULE 904 OF REGULATION S UNDER THE U.S. SECURITIES ACT AND IN COMPLIANCE WITH APPLICABLE LOCAL LAWS AND REGULATIONS, (C) IN COMPLIANCE WITH THE EXEMPTION FROM THE REGISTRATION REQUIREMENTS UNDER THE U.S. SECURITIES ACT PROVIDED BY (I) RULE 144 THEREUNDER IF AVAILABLE OR (II) RULE 144A THEREUNDER, IF AVAILABLE, AND IN EACH CASE IN ACCORDANCE WITH APPLICABLE U.S. STATE SECURITIES LAWS, (D) IN ANOTHER TRANSACTION THAT DOES NOT REQUIRE REGISTRATION UNDER THE U.S. SECURITIES ACT OR ANY APPLICABLE STATE SECURITIES LAWS, OR (E) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE U.S. SECURITIES ACT, PROVIDED THAT, IN THE CASE OF TRANSFERS PURSUANT TO (C)(I) OR (D) ABOVE, THE HOLDER HAS, PRIOR TO SUCH TRANSFER, FURNISHED TO THE CORPORATION AN OPINION OF COUNSEL OR OTHER EVIDENCE OF EXEMPTION, IN EITHER CASE REASONABLY SATISFACTORY TO THE CORPORATION. DELIVERY OF THIS CERTIFICATE MAY NOT CONSTITUTE “GOOD DELIVERY” IN SETTLEMENT OF TRANSACTIONS ON STOCK EXCHANGES IN CANADA.”;

 

12.Lost Certificate: If this Warrant Certificate or any replacement hereof becomes stolen, lost, mutilated or destroyed, the Corporation shall, on such terms as it may in its discretion impose, acting reasonably, issue and deliver a new certificate, in form identical hereto but with appropriate changes, representing any unexercised portion of the subscription rights represented hereby to replace the certificate so stolen, lost, mutilated or destroyed.

 

   
   

 

13.Language: The parties hereto acknowledge and confirm that they have requested that this Warrant Certificate as well as all notices and other documents contemplated hereby be drawn up in the English language. Les parties aux présentes reconnaissent et confirment qu’elles ont exigé que la présente convention ainsi que tous les avis et documents qui s’y rattachent soient rédigés en langue anglaise.

 

14.Transfer: The Warrants are transferable and the term “Warrantholder” shall mean and include any successor, transferee or assignee of the current or any future Warrantholder. The Warrants may be transferred by the Warrantholder completing and delivering to the Corporation the transfer form attached hereto as Schedule B and subject to compliance with all applicable laws including the applicable securities legislation and the policies of the TSX Venture Exchange.

 

15.Successors and Assigns: This Warrant Certificate shall enure to the benefit of the Warrantholder and the successors and assignees thereof and shall be binding upon the Corporation and the successors thereof.

 

16.Exercise Limitation: The Warrantholder agrees that it shall be prohibited from exercising any portion of this Warrant Certificate if the aggregate number of Common Shares of the Corporation owned or controlled, directly or indirectly, by the Warrantholder and any affiliates of the Warrantholder (including common shares of which the Warrantholder has deemed beneficial ownership), collectively, as a result of such exercise would equal or exceed 4.99% of the issued and outstanding common shares of the Corporation calculated on the date of exercise of the Warrant.

 

[Signature Page Follows.]

 

   
   

 

IN WITNESS WHEREOF the Corporation has caused this Warrant Certificate to be signed by an authorized officer as of the ______ day of ________________, 2020.

 

  BRIACELL THERAPEUICS CORP.
     
  By:  
    Authorized Officer

 

   
   

 

Schedule A

 

TO: BRIACELL THERAPEUTICS CORP.

 

SUBSCRIPTION FORM

 

The undersigned hereby:

 

1.subscribes for _______________ common shares (“Common Shares”) BriaCell Therapeutics Corp. (the “Corporation”) (or such other number of Common Shares or other securities to which such subscription entitles the undersigned in lieu thereof or in addition thereto pursuant to the provisions of the warrant certificate (the “Warrant Certificate”) dated November 16, 2020 issued by the Corporation) at the purchase price of $5.42 per Common Share (or at such other purchase price as may be in effect under the provisions of the Warrant Certificate) and on and subject to the other terms and conditions specified in the Warrant Certificate and hereunder and encloses herewith a certified cheque, bank draft or money order in lawful money of Canada payable to the Corporation or has transmitted same day funds by wire to such account as the Corporation directed the undersigned in payment of the subscription price.

 

2.exercises the cashless exercise provided in subsection 1(2) of the Warrant Certificate in respect of _______________ Common Shares (or such other number of Common Shares or other securities to which such subscription entitles the undersigned in lieu thereof or in addition thereto pursuant to the provisions of the Warrant Certificate) and subscribes for that number of Common Shares issuable to the undersigned pursuant to subsection 1(2) of the Warrant Certificate that the holder of the Warrant Certificate (the “Warrantholder”) would have been entitled to receive if the Warrantholder had exercised the right thereunder under subsection 1(1) of the Warrant Certificate on and subject to the other terms and conditions specified in the Warrant Certificate in respect thereof and hereunder.

 

The undersigned hereby represents and warrants to the Corporation that the undersigned (check one):

 

[  ] 1.(i) at the time of exercise of the warrants represented by the Warrant Certificate is not in the United States, (ii) is not a “U.S. person” as defined in Regulation S under the United States Securities Act of 1933, as amended, and is not exercising the warrants represented by the Warrant Certificate on behalf of a “U.S. person”, and (iii) did not execute or deliver this subscription form in the United States.

 

[  ] 2.is tendering with this exercise form a written opinion of counsel of recognized standing in form and substance reasonably satisfactory to the Corporation, or such other evidence acceptable to the Corporation, to the effect that the Common Shares to be delivered upon exercise of the Warrants are exempt from registration under the U.S. Securities Act and all applicable state securities laws of the United States.

 

“United States” and “U.S. person” are as defined in Regulation S under the U.S. Securities Act. If 2 is checked above, the undersigned will receive Common Shares bearing a legend noting U.S. resale restrictions.

 

   
   

 

The undersigned hereby directs that the Common Shares subscribed for be registered and delivered as follows:

 

Name in Full   Address (include Postal Code)   Number of Common Shares
         

 

DATED this ___ day of ______________, 20____.

 

  By:  

 

   
   

 

Schedule B

 

FORM OF TRANSFER

 

FOR VALUE RECEIVED, the undersigned hereby sells, assigns and transfers unto __________________________________________________________________________________ (include name and address of the transferee) Warrants exercisable for common shares of BriaCell Therapeutics Corp. (the “Corporation”) registered in the name of the undersigned on the register of the Corporation maintained therefor, and hereby irrevocably appoints _____________________________________________ the attorney of the undersigned to transfer the said securities on the books maintained by the Corporation with full power of substitution.

DATED this _________ day of ___________________, 202 .

Signature of Transferor guaranteed by:

 

__________________________________ _________________________________
Name of Bank or Trust Company: Signature of Transferor
_________________________________
_________________________________
_________________________________
  Address of Transferor

 

Instructions:

 

1.The name of the transferor must correspond with the name written upon the face of this Warrant Certificate in every particular without any changes whatsoever.

 

2.The signature of the Transferor on the Transfer Form must be guaranteed by an authorized officer of a chartered bank, trust company or an investment dealer who is a member of a recognized stock exchange, and the Warrantholder must pay any applicable transfer taxes or fees.

 

3.If the Transfer Form is signed by a trustee, executor, administrator, curator, guardian, attorney, officer of a corporation or any person acting in a judiciary or representative capacity, the Warrant Certificate must be accompanied by evidence of authority to sign satisfactory to the Corporation.

 

   

 

EX-4.6 5 ex4-6.htm

 

Exhibit 4.6

 

UNLESS PERMITTED UNDER SECURITIES LEGISLATION, THE HOLDER OF THIS SECURITY MUST NOT TRADE THE SECURITY BEFORE MARCH 17, 2021.

 

THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “U.S. SECURITIES ACT”) OR U.S. STATE SECURITIES LAWS. THESE SECURITIES MAY BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED, DIRECTLY OR INDIRECTLY, ONLY (A) TO BRIACELL THERAPEUTICS CORP. (THE “CORPORATION”), (B) OUTSIDE THE UNITED STATES IN COMPLIANCE WITH RULE 904 OF REGULATION S UNDER THE U.S. SECURITIES ACT AND IN COMPLIANCE WITH APPLICABLE LOCAL LAWS AND REGULATIONS, (C) IN COMPLIANCE WITH THE EXEMPTION FROM THE REGISTRATION REQUIREMENTS UNDER THE U.S. SECURITIES ACT PROVIDED BY (I) RULE 144 THEREUNDER IF AVAILABLE OR (II) RULE 144A THEREUNDER, IF AVAILABLE, AND IN EACH CASE IN ACCORDANCE WITH APPLICABLE U.S. STATE SECURITIES LAWS, (D) IN ANOTHER TRANSACTION THAT DOES NOT REQUIRE REGISTRATION UNDER THE U.S. SECURITIES ACT OR ANY APPLICABLE STATE SECURITIES LAWS, OR (E) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE U.S. SECURITIES ACT, PROVIDED THAT, IN THE CASE OF TRANSFERS PURSUANT TO (C)(I) OR (D) ABOVE, THE HOLDER HAS, PRIOR TO SUCH TRANSFER, FURNISHED TO THE CORPORATION AN OPINION OF COUNSEL OR OTHER EVIDENCE OF EXEMPTION, IN EITHER CASE REASONABLY SATISFACTORY TO THE CORPORATION. DELIVERY OF THIS CERTIFICATE MAY NOT CONSTITUTE “GOOD DELIVERY” IN SETTLEMENT OF TRANSACTIONS ON STOCK EXCHANGES IN CANADA.

 

WARRANTS TO PURCHASE
COMMON SHARES OF BRIACELL THERAPEUTICS CORP.

 

Warrant Certificate Number:

 

2020 November — BW 001

Number of Warrants:

 

4,890

 

THIS IS TO CERTIFY THAT for value received, [ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, NY 10004] (the “Warrantholder”) has the right to purchase in respect of each whole warrant (individually a “Warrant” and collectively the “Warrants”) represented by this certificate or by a replacement certificate (in either case this “Warrant Certificate”), one (1) fully paid and non-assessable common share (individually, a “Common Share” and collectively, the “Common Shares” and which terms shall include any shares or other securities to be issued in addition thereto or in substitution or replacement therefor as provided herein) of BriaCell Therapeutics Corp. (the “Corporation”), a corporation existing under the Business Corporations Act (British Columbia), as constituted on the date hereof, at a purchase price (the purchase price in effect from time to time being called the “Exercise Price”) of $5.42 per Common Share, subject to adjustment as provided herein, at any time up to 5:00 p.m. Toronto time (the “Expiry Time”) on November 16, 2025 (the “Expiry Date”).

 

The Corporation agrees that the Common Shares purchased pursuant to the exercise of the Warrants shall be and be deemed to be issued to the Warrantholder as of the close of business on the date on which this Warrant Certificate shall have been surrendered and payment made for such Common Shares as aforesaid.

 

 
 

 

Nothing contained herein shall confer any right upon the Warrantholder to subscribe for or purchase any Common Shares at any time after the Expiry Time and from and after the Expiry Time the Warrants and all rights under this Warrant Certificate shall be void and of no value.

 

The above provisions are subject to the following:

 

1.Exercise: In the event that the Warrantholder desires to exercise the right to purchase Common Shares conferred hereby, the Warrantholder shall (a) complete to the extent possible in the manner indicated, and execute a subscription form substantially in the form attached as Schedule A to this Warrant Certificate, (b) surrender this Warrant Certificate to the Corporation in accordance with Section 9 of this Warrant Certificate, and (c) pay the amount payable upon the exercise of such Warrants in respect of the Common Shares subscribed for by certified cheque, bank draft or money order in lawful money of Canada payable to the Corporation or by transmitting same day funds in lawful money of Canada by wire to such account as the Corporation shall direct the Warrantholder. Upon such surrender and payment as aforesaid, the Warrantholder shall be deemed for all purposes to be the holder of record of the number of Common Shares to be so issued and the Warrantholder shall be entitled to delivery of a certificate or certificates representing such Common Shares and the Corporation shall cause such certificate or certificates to be delivered to the Warrantholder at the address specified in the subscription form within three business days after such surrender and payment as aforesaid. No fractional Common Shares will be issuable upon any exercise of the Warrants and the Warrantholder will not be entitled to any cash payment or compensation in lieu of a fractional Common Share.

 

2.Partial Exercise: The Warrantholder may from time to time subscribe for and purchase any lesser number of Common Shares than the number of Common Shares expressed in this Warrant Certificate. In the event that the Warrantholder subscribes for and purchases any such lesser number of Common Shares prior to the Expiry Time on the Expiry Date, the Warrantholder shall be entitled to receive a replacement certificate representing the unexercised balance of the Warrants.

 

3.Not a Shareholder: The holding of the Warrants shall not constitute the Warrantholder a shareholder of the Corporation nor entitle the Warrantholder to any right or interest in respect thereof except as expressly provided in this Warrant Certificate.

 

4.Covenants, Representations and Warranties: The Corporation hereby represents and warrants that it is authorized to create and issue the Warrants and covenants and agrees that it will cause the Common Shares from time to time subscribed for and purchased in the manner provided in this Warrant Certificate and the certificate or certificates representing such Common Shares to be issued and that, at all times prior to the Expiry Time, it will reserve and there will remain unissued a sufficient number of Common Shares to satisfy the right of purchase provided for in this Warrant Certificate. The Corporation hereby further covenants and agrees that it will, at its expense, expeditiously use its best efforts to obtain the listing of such Common Shares (subject to issue or notice of issue) on each stock exchange or over-the-counter market on which the Common Shares are listed at the relevant time. All Common Shares which are issued upon the exercise of the right of purchase provided in this Warrant Certificate, upon payment therefor of the amount at which such Common Shares may be purchased pursuant to the provisions of this Warrant Certificate, shall be deemed to be fully paid and non-assessable shares and free from all taxes, liens and charges with respect to the issue thereof. The Corporation hereby represents and warrants that this Warrant Certificate is a valid and enforceable obligation of the Corporation, enforceable in accordance with the provisions of this Warrant Certificate.

 

 
 

 

5.Anti-Dilution Protection:

 

(1)Definitions: For the purposes of this section 5, unless there is something in the subject matter or context inconsistent therewith, the words and terms defined below shall have the respective meanings specified therefor in this subsection 5(1):

 

(a)Adjustment Period” means the period commencing on the date of issue of the Warrants and ending at the Expiry Time on the Expiry Date;

 

(b)Current Market Price” of the Common Shares at any date means the price per share equal to the weighted average price at which the Common Shares have traded on the TSX Venture Exchange or, if the Common Shares are not then listed on the TSX Venture Exchange, on such other Canadian stock exchange as may be selected by the directors of the Corporation for such purpose or, if the Common Shares are not then listed on any Canadian stock exchange, in the over-the-counter market, during the period of any ten (10) consecutive trading days ending on the third business day before such date; provided that the weighted average price shall be determined by dividing the aggregate sale price of all Common Shares sold on the said exchange or market, as the case may be, during such ten (10) consecutive trading days by the total number of Common Shares so sold; and provided further that if the Common Shares are not then listed on any Canadian stock exchange or traded in the over-the-counter market, then the Current Market Price shall be determined by a firm of independent chartered accountants selected by the directors of the Corporation;

 

(c)director” or “director of the Corporation” means a director of the Corporation at the relevant time and, unless otherwise specified herein, a reference to action “by the directors” means action by the directors of the Corporation as a board or, whenever empowered, action by any committee of the directors of the Corporation; and

 

(d)trading day” with respect to a stock exchange or over-the-counter market means a day on which such stock exchange or market is open for business.

 

(2)Adjustments: The Exercise Price and the number of Common Shares issuable to the Warrantholder pursuant to this Warrant Certificate shall be subject to adjustment from time to time in the events and in the manner provided as follows:

 

(a)If at any time during the Adjustment Period the Corporation shall:

 

(i)fix a record date for the issue of, or issue, Common Shares to the holders of all or substantially all of the outstanding Common Shares by way of a stock dividend;

 

(ii)fix a record date for the distribution to, or make a distribution to, the holders of all or substantially all of the outstanding Common Shares payable in Common Shares or securities exchangeable or exercisable for or convertible into Common Shares;

 

(iii)subdivide the outstanding Common Shares into a greater number of Common Shares; or

 

 
 

 

(iv)consolidate the outstanding Common Shares into a lesser number of Common Shares;

 

(any of such events in subclauses 5(2)(a)(i), 5(2)(a)(ii), 5(2)(a)(iii) and 5(2)(a)(iv) above being herein called a “Common Share Reorganization”), the Exercise Price shall be adjusted on the earlier of the record date on which holders of Common Shares are determined for the purposes of the Common Share Reorganization and the effective date of the Common Share Reorganization to the amount determined by multiplying the Exercise Price in effect immediately prior to such record date or effective date, as the case may be, by a fraction:

 

A.the numerator of which shall be the number of Common Shares outstanding on such record date or effective date, as the case may be, before giving effect to such Common Share Reorganization; and

 

B.the denominator of which shall be the number of Common Shares which will be outstanding immediately after giving effect to such Common Share Reorganization (including, in the case of a distribution of securities exchangeable or exercisable for or convertible into Common Shares, the number of Common Shares that would be outstanding had such securities all been exchanged or exercised for or converted into Common Shares on such date).

 

To the extent that any adjustment in the Exercise Price occurs pursuant to this clause 5(2)(a) as a result of the fixing by the Corporation of a record date for the distribution of securities exchangeable or exercisable for or convertible into Common Shares, the Exercise Price shall be readjusted immediately after the expiry of any relevant exchange, exercise or conversion right to the Exercise Price which would then be in effect based upon the number of Common Shares actually issued and remaining issuable after such expiry and shall be further readjusted in such manner upon the expiry of any further such right. Any Warrantholder who has not exercised it’s right to subscribe for and purchase Common Shares on or prior to the record date of such stock dividend or distribution or the effective date of such subdivision or consolidation, as the case may be, upon the exercise of such right thereafter shall be entitled to receive and shall accept in lieu of the number of Common Shares then subscribed for and purchased by such Warrantholder, at the Exercise Price determined in accordance with this clause 5(2)(a), the aggregate number of Common Shares that such Warrantholder would have been entitled to receive as a result of such Common Share Reorganization, if, on such record date or effective date, as the case may be, such Warrantholder had been the holder of record of the number of Common Shares so subscribed for and purchased.

 

(b)If, at any time during the Adjustment Period, the Corporation shall fix a record date for the issue or distribution to the holders of all or substantially all of the outstanding Common Shares of rights, options or warrants pursuant to which such holders are entitled, during a period expiring not more than 45 days after the record date for such issue (such period being the “Rights Period”), to subscribe for or purchase Common Shares or securities exchangeable or exercisable for or convertible into Common Shares at a price per share to the holder (or, in the case of securities exchangeable or exercisable for or convertible into Common Shares, at an exchange, exercise or conversion price per share) at the date of issue of such securities of less than 95% of the Current Market Price of the Common Shares on such record date (any of such events being called a “Rights Offering”), the Exercise Price shall be adjusted effective immediately after the record date for such Rights Offering to the amount determined by multiplying the Exercise Price in effect on such record date by a fraction:

 

 
 

 

(i)the numerator of which shall be the aggregate of

 

A.the number of Common Shares outstanding on the record date for the Rights Offering, and

 

B.the quotient determined by dividing

 

(1)either (a) the product of the number of Common Shares offered during the Rights Period pursuant to the Rights Offering and the price at which such Common Shares are offered, or, (b) the product of the exchange, exercise or conversion price of the securities so offered and the number of Common Shares for or into which the securities offered pursuant to the Rights Offering may be exchanged, exercised or converted, as the case may be, by

 

(2)the Current Market Price of the Common Shares as of the record date for the Rights Offering; and

 

(ii)the denominator of which shall be the aggregate of the number of Common Shares outstanding on such record date and the number of Common Shares offered pursuant to the Rights Offering (including, in the case of the issue or distribution of securities exchangeable or exercisable for or convertible into Common Shares, the number of Common Shares for or into which such securities may be exchanged, exercised or converted).

 

If, by the terms of the rights, options or warrants referred to in this clause 5(2)(b), there is more than one purchase, exchange, exercise or conversion price per Common Share, the aggregate price of the total number of additional Common Shares offered for subscription or purchase, or the aggregate exchange, exercise or conversion price of the exchangeable, exercisable or convertible securities so offered, shall be calculated for purposes of the adjustment on the basis of the lowest purchase, exchange, exercise or conversion price per Common Share, as the case may be. Any Common Shares owned by or held for the account of the Corporation shall be deemed not to be outstanding for the purpose of any such calculation. To the extent that any adjustment in the Exercise Price occurs pursuant to this clause 5(2)(b) as a result of the fixing by the Corporation of a record date for the issue or distribution of rights, options or warrants referred to in this clause 5(2)(b), the Exercise Price shall be readjusted immediately after the expiry of any relevant exchange, exercise or conversion right to the Exercise Price which would then be in effect based upon the number of Common Shares actually issued and remaining issuable after such expiry and shall be further readjusted in such manner upon the expiry of any further such right.

 

 
 

 

(c)If, at any time during the Adjustment Period, the Corporation shall fix a record date for the issue or distribution to the holders of all or substantially all of the outstanding Common Shares of:

 

(i)shares of the Corporation of any class other than Common Shares;

 

(ii)rights, options or warrants to acquire Common Shares or securities exchangeable or exercisable for or convertible into Common Shares or property or other assets of the Corporation (other than rights, options or warrants pursuant to which holders of Common Shares are entitled, during a period expiring not more than 45 days after the record date for such issue, to subscribe for or purchase Common Shares or securities exchangeable or exercisable for or convertible into Common Shares at a price per share (or in the case of securities exchangeable or exercisable for or convertible into Common Shares, at an exchange, exercise or conversion price per share) of at least 95% of the Current Market Price of the Common Shares on such record date);

 

(iii)evidences of indebtedness of the Corporation; or

 

(iv)any property or assets of the Corporation;

 

and if such issue or distribution does not constitute a Common Share Reorganization or a Rights Offering (any of such non-excluded events being herein called a “Special Distribution”), the Exercise Price shall be adjusted effective immediately after the record date for the Special Distribution to the amount determined by multiplying the Exercise Price in effect on the record date for the Special Distribution by a fraction:

 

A.the numerator of which shall be the difference between

 

(1)the product of the number of Common Shares outstanding on such record date and the Current Market Price of the Common Shares on such record date, and

 

(2)the fair market value, as determined by the directors of the Corporation, acting reasonably and in good faith, to the holders of Common Shares of the shares, rights, options, warrants, evidences of indebtedness or property or assets to be issued or distributed in the Special Distribution, and

 

B.the denominator of which shall be the product obtained by multiplying the number of Common Shares outstanding on such record date by the Current Market Price of the Common Shares on such record date.

 

Any Common Shares owned by or held for the account of the Corporation shall be deemed not to be outstanding for the purpose of such calculation. To the extent that any adjustment in the Exercise Price occurs pursuant to this clause 5(2)(c) as a result of the fixing by the Corporation of a record date for the issue or distribution of rights, options or warrants to acquire Common Shares or securities exchangeable or exercisable for or convertible into Common Shares referred to in this clause 5(2)(c), the Exercise Price shall be readjusted immediately after the expiry of any relevant exchange, exercise or conversion right to the amount which would then be in effect based upon the number of Common Shares issued and remaining issuable after such expiry and shall be further readjusted in such manner upon the expiry of any further such right.

 

 
 

 

(d)If, at any time during the Adjustment Period, there shall occur:

 

(i)a reclassification or redesignation of the Common Shares, a change of the Common Shares into other shares or securities or any other capital reorganization involving the Common Shares other than a Common Share Reorganization;

 

(ii)a consolidation, amalgamation, arrangement or merger of the Corporation with or into another body corporate which results in a reclassification or redesignation of the Common Shares or a change of the Common Shares into other shares or securities; or

 

(iii)the transfer of the undertaking or assets of the Corporation as an entirety or substantially as an entirety to another corporation or entity;

 

(any of such events being called a “Capital Reorganization”), after the effective date of the Capital Reorganization the Warrantholder shall be entitled to receive, and shall accept, for the same aggregate consideration, upon exercise of the Warrants, in lieu of the number of Common Shares to which the Warrantholder was theretofore entitled upon the exercise of the Warrants, the kind and aggregate number of shares and other securities or property resulting from the Capital Reorganization which the Warrantholder would have been entitled to receive as a result of the Capital Reorganization if, on the effective date thereof, the Warrantholder had been the registered holder of the number of Common Shares which the Warrantholder was theretofore entitled to purchase or receive upon the exercise of the Warrants. If necessary, as a result of any such Capital Reorganization, appropriate adjustments shall be made in the application of the provisions of this Warrant Certificate with respect to the rights and interests thereafter of the Warrantholder to the end that the provisions of this Warrant Certificate shall thereafter correspondingly be made applicable as nearly as may reasonably be possible in relation to any shares or other securities or property thereafter deliverable upon the exercise of the Warrants.

 

(e)If at any time during the Adjustment Period any adjustment or readjustment in the Exercise Price shall occur pursuant to the provisions of clause 5(2)(a), 5(2)(b) or 5(2)(c) of this Warrant Certificate, then the number of Common Shares purchasable upon the subsequent exercise of the Warrants shall be simultaneously adjusted or readjusted, as the case may be, by multiplying the number of Common Shares purchasable upon the exercise of the Warrants immediately prior to such adjustment or readjustment by a fraction which shall be the reciprocal of the fraction used in the adjustment or readjustment of the Exercise Price.

 

 
 

 

(3)Rules: The following rules and procedures shall be applicable to adjustments made pursuant to subsection 5(2) of this Warrant Certificate:

 

(a)Subject to the following clauses of this subsection 5(3), any adjustment made pursuant to subsection 5(2) hereof shall be cumulative and shall be made successively whenever an event referred to therein shall occur.

 

(b)No adjustment in the Exercise Price shall be required unless such adjustment would result in a change of at least one per cent in the then Exercise Price and no adjustment shall be made in the number of Common Shares purchasable upon the exercise of the Warrants unless it would result in a change of at least one one-hundredth of a Common Share; provided, however, that any adjustments which except for the provision of this clause 5(3)(b) would otherwise have been required to be made shall be carried forward and taken into account in any subsequent adjustment. Notwithstanding any other provision of subsection 5(2) hereof, no adjustment of the Exercise Price shall be made which would result in an increase in the Exercise Price or a decrease in the number of Common Shares issuable upon the exercise of the Warrants (except in respect of the Common Share Reorganization described in subclause 5(2)(a)(iv) hereof or a Capital Reorganization described in subclause 5(2)(d)(ii) hereof).

 

(c)No adjustment in the Exercise Price or in the number or kind of securities purchasable upon the exercise of the Warrants shall be made in respect of any event described in section 5 hereof if the Warrantholder is entitled to participate in such event on the same terms mutatis mutandis as if the Warrantholder had exercised the Warrants prior to or on the record date or effective date, as the case may be, of such event.

 

(d)No adjustment in the Exercise Price or in the number of Common Shares purchasable upon the exercise of the Warrants shall be made pursuant to subsection 5(2) hereof in respect of the issue from time to time of Common Shares pursuant to this Warrant Certificate or pursuant to any stock option, stock purchase or stock bonus plan in effect from time to time for directors, officers or employees of the Corporation and/or any subsidiary of the Corporation and any such issue, and any grant of options in connection therewith, shall be deemed not to be a Common Share Reorganization, a Rights Offering nor any other event described in subsection 5(2) hereof.

 

(e)If, at any time during the Adjustment Period, the Corporation shall take any action affecting the Common Shares, other than an action or event described in subsection 5(2) hereof, which, in the opinion of the directors of the Corporation, acting reasonably and in good faith, would have a material adverse effect upon the rights of Warrantholders, either or both the Exercise Price and the number of Common Shares purchasable upon exercise of the Warrants shall be adjusted in such manner and at such time by action by the directors of the Corporation, in their sole discretion, acting reasonably and in good faith, but subject to the prior written consent of the TSX Venture Exchange, as may be equitable in the circumstances. Failure of the taking of action by the directors of the Corporation so as to provide for an adjustment prior to the effective date of any action by the Corporation affecting the Common Shares shall be deemed to be conclusive evidence that the directors of the Corporation have determined that it is equitable to make no adjustment in the circumstances.

 

 
 

 

(f)If the Corporation shall set a record date to determine holders of Common Shares for the purpose of entitling such holders to receive any dividend or distribution or any subscription or purchase rights and shall, thereafter and before the distribution to such holders of any such dividend, distribution or subscription or purchase rights, legally abandon its plan to pay or deliver such dividend, distribution or subscription or purchase rights, then no adjustment in the Exercise Price or the number of Common Shares purchasable upon the exercise of the Warrants shall be required by reason of the setting of such record date.

 

(g)In any case in which this Warrant Certificate shall require that an adjustment shall become effective immediately after a record date for an event referred to in subsection 5(2) hereof, the Corporation may defer, until the occurrence of such event:

 

(i)issuing to the Warrantholder, to the extent that the Warrants are exercised after such record date and before the occurrence of such event, the additional Common Shares or other securities issuable upon such exercise by reason of the adjustment required by such event; and

 

(ii)delivering to the Warrantholder any distribution declared with respect to such additional Common Shares or other securities after such record date and before such event;

 

provided, however, that the Corporation shall deliver to the Warrantholder an appropriate instrument evidencing the right of the Warrantholder upon the occurrence of the event requiring the adjustment, to an adjustment in the Exercise Price and/or the number of Common Shares purchasable upon the exercise of the Warrants and to such distribution declared with respect to any such additional Common Shares issuable upon the exercise of the Warrants.

 

(h)In the absence of a resolution of the directors of the Corporation fixing a record date for a Rights Offering, the Corporation shall be deemed to have fixed as the record date therefor the date of the issue of the rights, options or warrants issued pursuant to the Rights Offering.

 

(i)If a dispute shall at any time arise with respect to adjustments of the Exercise Price or the number of Common Shares purchasable upon the exercise of the Warrants, such disputes shall be conclusively determined by the auditors of the Corporation or if they are unable or unwilling to act, by such other firm of independent chartered accountants as may be selected by the directors of the Corporation and any such determination shall be conclusive evidence of the correctness of any adjustment made pursuant to subsection 5(2) hereof and shall be binding upon the Corporation and the Warrantholder.

 

(j)As a condition precedent to the taking of any action which would require an adjustment pursuant to subsection 5(2) hereof, including the Exercise Price and the number or class of Common Shares or other securities which are to be received upon the exercise thereof, the Corporation shall take any action which may, in the opinion of counsel to the Corporation, be necessary in order that the Corporation may validly and legally issue as fully paid and non-assessable shares all of the Common Shares or other securities which the Warrantholder is entitled to receive in accordance with the provisions of this Warrant Certificate.

 

 
 

 

(4)Notice: At least twenty-one (21) days prior to the earlier of the record date or effective date of any event which requires or might require an adjustment in any of the rights of the Warrantholder under this Warrant Certificate, including the Exercise Price or the number of Common Shares which may be purchased under this Warrant Certificate, the Corporation shall deliver to the Warrantholder a certificate of the Corporation specifying the particulars of such event and, if determinable, the required adjustment and the calculation of such adjustment. In case any adjustment for which a notice in this subsection 5(4) has been given is not then determinable, the Corporation shall promptly after such adjustment is determinable deliver to the Warrantholder a certificate providing the calculation of such adjustment. The Corporation hereby covenants and agrees that the register of transfers and share transfer books for the Common Shares will be open, and that the Corporation will not take any action which might deprive the Warrantholder of the opportunity of exercising the rights of subscription contained in this Warrant Certificate, during such 21 day period.

 

6.Further Assurances: The Corporation hereby covenants and agrees that it will do, execute, acknowledge and deliver, or cause to be done, executed, acknowledged and delivered, all and every such other act, deed and assurance as the Warrantholder shall reasonably require for the better accomplishing and effectuating of the intentions and provisions of this Warrant Certificate.

 

7.Time of Essence: Time shall be of the essence of this Warrant Certificate.

 

8.Governing Laws: This Warrant Certificate shall be construed in accordance with the laws of the Province of Ontario and the federal laws of Canada applicable therein.

 

9.Notices: All notices or other communications to be given under this Warrant Certificate shall be delivered by hand, by facsimile or by emailed portable document format (“PDF”) and, if delivered by hand, shall be deemed to have been given on the delivery date and, if sent by facsimile or emailed PDF, on the date of transmission if sent before 5:00 p.m., Toronto time, on a business day or, if sent after 5:00 p.m., Toronto time, or such day is not a business day, on the first business day following the date of transmission.

 

Notices to the Corporation shall be addressed to:

 

BriaCell Therapeutics Corp.

3rd Floor, Bellevue Centre

235-15th Street
West Vancouver, British Columbia V7T 2X1

 

  Attention: Jamieson Bondarenko
  Email: jbondarenko@briacell.com

 

with a copy (which shall not constitute notice) to:

 

Bennett Jones LLP

3400 One First Canadian Place

P.O. Box 130

Toronto, ON M5X 1A4

 

  Attention: Aaron Sonshine
  Email: SonshineA@bennettjones.com

 

Notices to the Warrantholder shall be addressed to the address of the Warrantholder set out on the face page of this Warrant Certificate.

 

 
 

 

The Corporation or the Warrantholder may change its address for service by notice in writing to the other of them specifying its new address for service under this Warrant Certificate.

 

10.Legends on Common Shares: Any certificate representing Common Shares issued upon the exercise of the Warrants prior to the date which is four months and one day after the date hereof will bear the following legends:

 

“UNLESS PERMITTED UNDER SECURITIES LEGISLATION, THE HOLDER OF THIS SECURITY MUST NOT TRADE THE SECURITY BEFORE MARCH 17, 2021.”

 

and if required:

 

“WITHOUT PRIOR WRITTEN APPROVAL OF THE TSX VENTURE EXCHANGE AND COMPLIANCE WITH ALL APPLICABLE SECURITIES LEGISLATION, THE SECURITIES REPRESENTED BY THIS CERTIFICATE MAY NOT BE SOLD, TRANSFERRED, HYPOTHECATED OR OTHERWISE TRADED ON OR THROUGH THE FACILITIES OF THE TSX VENTURE EXCHANGE OR OTHERWISE IN CANADA OR TO OR FOR THE BENEFIT OF A CANADIAN RESIDENT MARCH 17, 2021.”;

 

provided that at any time subsequent to the date which is four months and one day after the date hereof any certificate representing such Common Shares may be exchanged for a certificate or certificates bearing no such legends. The Corporation hereby covenants and agrees that it will use the best efforts thereof to deliver or to cause to be delivered a certificate or certificates representing such Common Shares bearing no such legends within three business days after receipt of the legended certificate or certificates.

 

 
 

 

11.United States Restrictions on Exercise and Resale: Any certificate representing Common Shares issued upon the exercise of the Warrants will bear the following legend:

 

“THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “U.S. SECURITIES ACT”) OR U.S. STATE SECURITIES LAWS. THESE SECURITIES MAY BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED, DIRECTLY OR INDIRECTLY, ONLY (A) TO BRIACELL THERAPEUTICS CORP. (THE “CORPORATION”), (B) OUTSIDE THE UNITED STATES IN COMPLIANCE WITH RULE 904 OF REGULATION S UNDER THE U.S. SECURITIES ACT AND IN COMPLIANCE WITH APPLICABLE LOCAL LAWS AND REGULATIONS, (C) IN COMPLIANCE WITH THE EXEMPTION FROM THE REGISTRATION REQUIREMENTS UNDER THE U.S. SECURITIES ACT PROVIDED BY (I) RULE 144 THEREUNDER IF AVAILABLE OR (II) RULE 144A THEREUNDER, IF AVAILABLE, AND IN EACH CASE IN ACCORDANCE WITH APPLICABLE U.S. STATE SECURITIES LAWS, (D) IN ANOTHER TRANSACTION THAT DOES NOT REQUIRE REGISTRATION UNDER THE U.S. SECURITIES ACT OR ANY APPLICABLE STATE SECURITIES LAWS, OR (E) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE U.S. SECURITIES ACT, PROVIDED THAT, IN THE CASE OF TRANSFERS PURSUANT TO (C)(I) OR (D) ABOVE, THE HOLDER HAS, PRIOR TO SUCH TRANSFER, FURNISHED TO THE CORPORATION AN OPINION OF COUNSEL OR OTHER EVIDENCE OF EXEMPTION, IN EITHER CASE REASONABLY SATISFACTORY TO THE CORPORATION. DELIVERY OF THIS CERTIFICATE MAY NOT CONSTITUTE “GOOD DELIVERY” IN SETTLEMENT OF TRANSACTIONS ON STOCK EXCHANGES IN CANADA.”;

 

12.Lost Certificate: If this Warrant Certificate or any replacement hereof becomes stolen, lost, mutilated or destroyed, the Corporation shall, on such terms as it may in its discretion impose, acting reasonably, issue and deliver a new certificate, in form identical hereto but with appropriate changes, representing any unexercised portion of the subscription rights represented hereby to replace the certificate so stolen, lost, mutilated or destroyed.

 

13.Language: The parties hereto acknowledge and confirm that they have requested that this Warrant Certificate as well as all notices and other documents contemplated hereby be drawn up in the English language. Les parties aux présentes reconnaissent et confirment qu’elles ont exigé que la présente convention ainsi que tous les avis et documents qui s’y rattachent soient rédigés en langue anglaise.

 

14.Transfer:

 

(1)The Warrants are non-assignable and non-transferable by the Warrantholder except with the prior written consent of the Corporation and subject to compliance with all applicable laws including the applicable securities legislation, the policies of the TSX Venture Exchange and Subsection 14(2) hereof. With the prior written consent of the Corporation, and subject to Subsection 14(2), the Warrants may be transferred or assigned by the Warrantholder by completing and delivering to the Corporation the transfer form attached hereto as Schedule B.

 

(2)Pursuant to FINRA Rule 5110(e)(1), neither the Warrants nor any Common Shares issued upon exercise of the Warrant shall be sold, transferred, assigned, pledged, or hypothecated, or be the subject of any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the securities by any person before the earlier of: (i) the expiry of a period of 180 days immediately following the date of effectiveness or commencement of sales of the Corporation’s U.S. initial public offering of securities (the “Offering”) pursuant to the Corporation’s registration statement, and amendments thereto, on Form F-1 (File No. 333-234292), and (ii) the date of termination of the Offering if no securities of the Corporation were sold in the Offering, except:

 

(a)the transfer of any security by operation of law or by reason of reorganization of the Corporation;

 

 
 

 

(b)the transfer of any security to any FINRA member firm participating in the Offering and the officers or partners thereof, if all securities so transferred remain subject to the lock-up restriction in this Section 14(2) for the remainder of the time period;

 

(c)the transfer of any security if the aggregate amount of securities of the Corporation held by the Warrantholder or related person do not exceed 1% of the securities being offered in the Offering;

 

(d)the transfer of any security that is beneficially owned on a pro-rata basis by all equity owners of an investment fund, provided that no participating member manages or otherwise directs investments by the fund, and participating members in the aggregate do not own more than 10% of the equity in the fund; or

 

(e)the exercise or conversion of any security, if all securities received remain subject to the lock-up restriction in this Section 14(2) for the remainder of the time period.

 

15.Successors and Assigns: This Warrant Certificate shall enure to the benefit of the Warrantholder and the successors and assignees thereof and shall be binding upon the Corporation and the successors thereof.

 

[Signature Page Follows.]

 

 
 

 

IN WITNESS WHEREOF the Corporation has caused this Warrant Certificate to be signed by an authorized officer as of the ______ day of ________________, 2020.

 

  BRIACELL THERAPEUICS CORP.
   
  By:  
    Authorized Officer

 

 
 

 

Schedule A

 

TO: BRIACELL THERAPEUTICS CORP.

 

SUBSCRIPTION FORM

 

The undersigned hereby:

 

1.subscribes for _______________ common shares (“Common Shares”) BriaCell Therapeutics Corp. (the “Corporation”) (or such other number of Common Shares or other securities to which such subscription entitles the undersigned in lieu thereof or in addition thereto pursuant to the provisions of the warrant certificate (the “Warrant Certificate”) dated November 16, 2020 issued by the Corporation) at the purchase price of $5.42 per Common Share (or at such other purchase price as may be in effect under the provisions of the Warrant Certificate) and on and subject to the other terms and conditions specified in the Warrant Certificate and hereunder and encloses herewith a certified cheque, bank draft or money order in lawful money of Canada payable to the Corporation or has transmitted same day funds by wire to such account as the Corporation directed the undersigned in payment of the subscription price.

 

The undersigned hereby represents and warrants to the Corporation that the undersigned (check one):

 

[  ]1.(i) at the time of exercise of the warrants represented by the Warrant Certificate is not in the United States, (ii) is not a “U.S. person” as defined in Regulation S under the United States Securities Act of 1933, as amended, and is not exercising the warrants represented by the Warrant Certificate on behalf of a “U.S. person”, and (iii) did not execute or deliver this subscription form in the United States.

 

[  ]2.is tendering with this exercise form a written opinion of counsel of recognized standing in form and substance reasonably satisfactory to the Corporation, or such other evidence acceptable to the Corporation, to the effect that the Common Shares to be delivered upon exercise of the Warrants are exempt from registration under the U.S. Securities Act and all applicable state securities laws of the United States.

 

“United States” and “U.S. person” are as defined in Regulation S under the U.S. Securities Act. If 2 is checked above, the undersigned will receive Common Shares bearing a legend noting U.S. resale restrictions.

 

The undersigned hereby directs that the Common Shares subscribed for be registered and delivered as follows:

 

Name in Full Address (include Postal Code) Number of Common Shares

 

 

DATED this ___ day of ______________, 20____.

 

  By:  

 

 
 

 

Schedule B

 

FORM OF TRANSFER

 

FOR VALUE RECEIVED, the undersigned hereby sells, assigns and transfers unto __________________________________________________________________________________ (include name and address of the transferee) Warrants exercisable for common shares of BriaCell Therapeutics Corp. (the “Corporation”) registered in the name of the undersigned on the register of the Corporation maintained therefor, and hereby irrevocably appoints _____________________________________________ the attorney of the undersigned to transfer the said securities on the books maintained by the Corporation with full power of substitution.

 

DATED this _________ day of ___________________, 202 .

 

Signature of Transferor guaranteed by:

 

       
Name of Bank or Trust Company:   Signature of Transferor  
       
       
       
       
       
       
  Address of Transferor  

 

Instructions:

 

1.The name of the transferor must correspond with the name written upon the face of this Warrant Certificate in every particular without any changes whatsoever.

 

2.The signature of the Transferor on the Transfer Form must be guaranteed by an authorized officer of a chartered bank, trust company or an investment dealer who is a member of a recognized stock exchange, and the Warrantholder must pay any applicable transfer taxes or fees.

 

3.If the Transfer Form is signed by a trustee, executor, administrator, curator, guardian, attorney, officer of a corporation or any person acting in a judiciary or representative capacity, the Warrant Certificate must be accompanied by evidence of authority to sign satisfactory to the Corporation.

 

 

 

EX-10.44 6 ex10-44.htm

 

Exhibit 10.44

 

PUBLIC HEALTH SERVICE

 

COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT

 

This Agreement is based on the model Cooperative Research and Development Agreement (“CRADA”) adopted by the U.S. Public Health Service (“PHS”) Technology Transfer Policy Board for use by components of the National Institutes of Health (“NIH”), the Centers for Disease Control and Prevention (“CDC”), and the Food and Drug Administration (“FDA”), which are agencies of the PHS within the Department of Health and Human Services (“HHS”).

 

This Cover Page identifies the Parties to this CRADA:

 

The U.S. Department of Health and Human Services, as represented by
National Cancer Institute

an Institute or Center (hereinafter referred to as the “IC”) of the
NIH

 

and

 

BriaCell Therapeutics Corp.
hereinafter referred to as the “Collaborator”,

having offices at 820 Heinz Avenue, Berkley, California 94710,
created and operating under the laws of Delaware.

 

PHS CRADA

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COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT

 

Article 1. Introduction

 

This CRADA between IC and Collaborator will be effective when signed by the Parties, which are identified on both the Cover Page and the Signature Page. The official contacts for the Parties are identified on the Contacts Information Page. Publicly available information regarding this CRADA appears on the Summary Page. The research and development activities that will be undertaken by IC and Collaborator in the course of this CRADA are detailed in the Research Plan, attached as Appendix A. The staffing, funding, and materials contributions of the Parties are set forth in Appendix B.

 

Article 2. Definitions

 

The terms listed in this Article will carry the meanings indicated throughout the CRADA. To the extent a definition of a term as provided in this Article is inconsistent with a corresponding definition in the applicable sections of either the United States Code (U.S.C.) or the Code of Federal Regulations (C.F.R.), the definition in the U.S.C. or C.F.R. will control.

 

2.1Affiliate” means any corporation or other business entity controlled by, controlling, or under common control with Collaborator at any time during the term of the CRADA. For this purpose, “control” means direct or indirect beneficial ownership of at least fifty percent (50%) of the voting stock or at least fifty percent (50%) interest in the income of the corporation or other business entity.

 

2.2Background Invention” means an Invention conceived and first actually reduced to practice before the Effective Date.

 

2.3Collaborator Materials” means all tangible materials not first produced in the performance of this CRADA that are owned or controlled by Collaborator and used in the performance of the Research Plan.

 

2.4Confidential Information” means confidential scientific, business, or financial information provided that the information does not include:

 

(a)information that is publicly known or that is available from public sources;
(b)information that has been made available by its owner to others without a confidentiality obligation;
(c)information that is already known by the receiving Party, or information that is independently created or compiled by the receiving Party without reference to or use of the provided information; or
(d)information that relates to potential hazards or cautionary warnings associated with the production, handling, or use of the subject matter of the Research Plan.

 

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2.5Cooperative Research and Development Agreement” or “CRADA” means this Agreement, entered into pursuant to the Federal Technology Transfer Act of 1986, as amended (15 U.S.C. §§ 3710a et seq.), and Executive Order 12591 of April 10, 1987.

 

2.6CRADA Data” means all recorded information first produced in the performance of the Research Plan.

 

2.7CRADA Materials” means all tangible materials first produced in the performance of the Research Plan other than CRADA Data.

 

2.8CRADA Subject Invention” means any Invention of either or both Parties, conceived or first actually reduced to practice in the performance of the Research Plan.

 

2.9Effective Date” means the date of the last signature of the Parties executing this Agreement.

 

2.10Government” means the Government of the United States of America.

 

2.11“IC Materials” means all tangible materials not first produced in the performance of this CRADA that are owned or controlled by IC and used in the performance of the Research Plan.

 

2.12Invention” means any invention or discovery that is or may be patentable or otherwise protected under Title 35 of the United States Code, or any novel variety of plant which is or may be protectable under the Plant Variety Protection Act, 7 U.S.C. §§ 2321 et seq.

 

2.13Patent Application” means an application for patent protection for a CRADA Subject Invention with the United States Patent and Trademark Office (“U.S.P.T.O.”) or the corresponding patent-issuing authority of another nation.

 

2.14Patent” means any issued United States patent, any international counterpart(s), and any corresponding grant(s) by a non-U.S. government in place of a patent.

 

2.15Principal Investigator(s)” or “PI(s)” means the person(s) designated by the Parties who will be responsible for the scientific and technical conduct of the Research Plan.

 

2.16Research Plan” means the statement in Appendix A of the respective research and development commitments of the Parties.

 

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Article 3. Cooperative Research and Development

 

3.1Performance of Research and Development. The research and development activities to be carried out under this CRADA will be performed solely by the Parties identified on the Cover Page unless specifically stated elsewhere in this Agreement. The PIs will be responsible for the scientific and technical conduct of this project on behalf of their employers. Any Collaborator employees who will work at IC facilities will be required to sign an agreement appropriately modified in view of the terms of this CRADA.

 

3.2Research Plan. The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

 

3.3Use and Disposition of Collaborator Materials and IC Materials. The Parties agree to use Collaborator Materials and IC Materials only in accordance with the Research Plan, not to transfer these materials to third parties except in accordance with the Research Plan or as approved by the owning or providing Party, and, upon expiration or termination of the CRADA, to dispose of these materials as directed by the owning or providing Party.

 

3.4Third-Party Rights in Collaborator’s CRADA Subject Inventions. If Collaborator has received (or will receive) support of any kind from a third party in exchange for rights in any of Collaborator’s CRADA Subject Inventions, Collaborator agrees to ensure that its obligations to the third party are both consistent with Articles 6 through 8 and subordinate to Article 7 of this CRADA.

 

3.5Disclosures to IC. Prior to execution of this CRADA, Collaborator agrees to disclose to IC all instances in which outstanding royalties are due under a PHS license agreement, and in which Collaborator had a PHS license terminated in accordance with 37 C.F.R. § 404.10. These disclosures will be treated as Confidential Information upon request by Collaborator in accordance with Paragraphs 2.4, 8.3, and 8.4.

 

Article 4. Reports

 

4.1Interim Research and Development Reports. The PIs should exchange information regularly, in writing. This exchange may be accomplished through meeting minutes, annual reports, detailed correspondence, and circulation of draft manuscripts.

 

4.2Final Research and Development Reports. The Parties will exchange final reports of their results within four (4) months after the expiration or termination of this CRADA. These reports will set forth the technical progress made; any publications arising from the research; and the existence of invention disclosures of potential CRADA Subject Inventions and/or any corresponding Patent Applications.

 

4.3Fiscal Reports. If Collaborator has agreed to provide funding to IC under this CRADA and upon the request of Collaborator, then concurrent with the exchange of final research and development reports according to Paragraph 4.2, IC will submit to Collaborator a statement of all costs incurred by IC for the CRADA. If the CRADA has been terminated, IC will specify any costs incurred before the date of termination for which IC has not received funds from Collaborator, as well as for all reasonable termination costs including the cost of returning Collaborator property or removal of abandoned Collaborator property, for which Collaborator will be responsible.

 

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Article 5. Staffing, Financial, and Materials Obligations

 

5.1IC and Collaborator Contributions. The contributions of any staff, funds, materials, and equipment by the Parties are set forth in Appendix B. The Federal Technology Transfer Act of 1986, 15 U.S.C. § 3710a(d)(1) prohibits IC from providing funds to Collaborator for any research and development activities under this CRADA.

 

5.2IC Staffing. No IC employees will devote 100% of their effort or time to the research and development activities under this CRADA. IC will not use funds provided by Collaborator under this CRADA for IC personnel to pay the salary of any permanent IC employee. Although personnel hired by IC using CRADA funds will focus principally on CRADA research and development activities, Collaborator acknowledges that these personnel may nonetheless make contributions to other research and development activities, and the activities will be outside the scope of this CRADA.

 

5.3Collaborator Funding. Collaborator acknowledges that Government funds received by Collaborator from an agency of the Department of Health and Human Services may not be used to fund IC under this CRADA. If Collaborator has agreed to provide funds to IC then the payment schedule appears in Appendix B and Collaborator will make payments according to that schedule. If Collaborator fails to make any scheduled payment, IC will not be obligated to perform any of the research and development activities specified herein or to take any other action required by this CRADA until the funds are received. IC will use these funds exclusively for the purposes of this CRADA. Each Party will maintain separate and distinct current accounts, records, and other evidence supporting its financial obligations under this CRADA and, upon written request, will provide the other Party a Fiscal Report according to Paragraph 4.3, which delineates all payments made and all obligated expenses, along with the Final Research Report described in Paragraph 4.2.

 

5.4Capital Equipment. Collaborator’s commitment, if any, to provide IC with capital equipment to enable the research and development activities under the Research Plan appears in Appendix B. If Collaborator transfers to IC the capital equipment or provides funds for IC to purchase it, then IC will own the equipment. If Collaborator loans capital equipment to IC for use during the CRADA, Collaborator will be responsible for paying all costs and fees associated with the transport, installation, maintenance, repair, removal, or disposal of the equipment, and IC will not be liable for any damage to the equipment.

 

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Article 6. Intellectual Property

 

6.1Ownership of CRADA Subject Inventions, CRADA Data, and CRADA Materials. Subject to the Government license described in Paragraph 7.5, the sharing requirements of Paragraph 8.1, and the regulatory filing requirements of Paragraph 8.2, the producing Party will retain sole ownership of and title to all CRADA Subject Inventions, all copies of CRADA Data, and all CRADA Materials produced solely by its employee(s). The Parties will own jointly all CRADA Subject Inventions invented jointly and all copies of CRADA Data and all CRADA Materials developed jointly.

 

6.2Reporting. The Parties will promptly report to each other in writing each CRADA Subject Invention reported by their respective personnel, and any Patent Applications filed thereon, resulting from the research and development activities conducted under this CRADA. Each Party will report all CRADA Subject Inventions to the other Party in sufficient detail to determine inventorship, which will be determined in accordance with U.S. patent law. These reports will be treated as Confidential Information in accordance with Article 8. Formal reports will be made by and to the Patenting and Licensing Offices identified on the Contacts Information Page herein.

 

6.3Filing of Patent Applications. Each Party will make timely decisions regarding the filing of Patent Applications on the CRADA Subject Inventions made solely by its employee(s), and will notify the other Party in advance of filing. Collaborator will have the first opportunity to file a Patent Application on joint CRADA Subject Inventions and will notify PHS of its decision within sixty (60) days of an Invention being reported or at least thirty (30) days before any patent filing deadline, whichever occurs sooner. If Collaborator fails to notify PHS of its decision within that time period or notifies PHS of its decision not to file a Patent Application, then PHS has the right to file a Patent Application on the joint CRADA Subject Invention. Neither Party will be obligated to file a Patent Application. Collaborator will place the following statement in any Patent Application it files on a CRADA Subject Invention: “This invention was created in the performance of a Cooperative Research and Development Agreement with the National Institutes of Health, an Agency of the Department of Health and Human Services. The Government of the United States has certain rights in this invention.” If either Party files a Patent Application on a joint CRADA Subject Invention, then the filing Party will include a statement within the Patent Application that clearly identifies the Parties and states that the joint CRADA Subject Invention was made under this CRADA.

 

6.4Patent Expenses. Unless agreed otherwise, the Party filing a Patent Application will pay all preparation and filing expenses, prosecution fees, issuance fees, post issuance fees, patent maintenance fees, annuities, interference expenses, and attorneys’ fees for that Patent Application and any resulting Patent(s). If a license to any CRADA Subject Invention is granted to Collaborator, then Collaborator will be responsible for all expenses and fees, past and future, in connection with the preparation, filing, prosecution, and maintenance of any Patent Applications and Patents claiming exclusively-licensed CRADA Subject Inventions and will be responsible for a pro-rated share, divided equally among all licensees, of those expenses and fees for non-exclusively licensed CRADA Subject Inventions. Collaborator may waive its exclusive option rights at any time, and incur no subsequent financial obligation for those Patent Application(s) or Patent(s)

 

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6.5Prosecution of Patent Applications. The Party filing a Patent Application will provide the non-filing Party with a copy of any official communication relating to prosecution of the Patent Application within thirty (30) days of transmission of the communication. Each Party will also provide the other Party with the power to inspect and make copies of all documents retained in the applicable Patent Application or Patent file. The Parties agree to consult with each other regarding the prosecution of Patent Applications directed to joint CRADA Subject Inventions. If Collaborator elects to file and prosecute Patent Applications on joint CRADA Subject Inventions, then Collaborator agrees to use the U.S.P.T.O. Customer Number Practice and/or grant PHS a power(s) of attorney (or equivalent) necessary to assure PHS access to its intellectual property rights in these Patent Applications. PHS and Collaborator will cooperate with each other to obtain necessary signatures on Patent Applications, assignments, or other documents.

 

Article 7. Licensing

 

7.1Background Inventions. Other than as specifically stated in this Article 7, nothing in this CRADA will be construed to grant any rights in one Party’s Background Invention(s) to the other Party, except to the extent necessary for the Parties to conduct the research and development activities described in the Research Plan.

 

7.2Collaborator’s License Option to CRADA Subject Inventions. With respect to Government rights to any CRADA Subject Invention made solely by an IC employee(s) or made jointly by an IC employee(s) and a Collaborator employee(s) for which a Patent Application was filed, PHS hereby grants to Collaborator an exclusive option to elect an exclusive or nonexclusive commercialization license. The license will be substantially in the form of the appropriate model PHS license agreement and will fairly reflect the nature of the CRADA Subject Invention, the relative contributions of the Parties to the CRADA Subject Invention and the CRADA, a plan for the development and marketing of the CRADA Subject Invention, the risks incurred by Collaborator, and the costs of subsequent research and development needed to bring the CRADA Subject Invention to the marketplace. The field of use of the license will not exceed the scope of the Research Plan.

 

7.3Exercise of Collaborator’s License Option. To exercise the option of Paragraph 7.2 Collaborator must submit a written notice to the PHS Patenting and Licensing Contact identified on the Contacts Information Page (and provide a copy to the IC Contact for CRADA Notices) within three (3) months after either (i) Collaborator receives written notice from PHS that the Patent Application has been filed or (ii) the date on which Collaborator files the Patent Application. The written notice exercising this option will include a completed “Application for License to Public Health Service Inventions” and will initiate a negotiation period that expires nine (9) months after the exercise of the option. If PHS has not responded in writing to the last proposal by Collaborator within this nine (9) month period, the negotiation period will be extended to expire one (1) month after PHS so responds, during which month Collaborator may accept in writing the final license proposal of PHS. In the absence of Collaborator’s exercise of the option, or upon election of a nonexclusive license, PHS will be free to license the CRADA Subject Invention to others. These time periods may be extended at the sole discretion of PHS upon good cause shown in writing by Collaborator.

 

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7.4Government License in IC Sole CRADA Subject Inventions and Joint CRADA Subject Inventions. Pursuant to 15 U.S.C. § 3710a(b)(1)(A), for CRADA Subject Inventions owned solely by IC or jointly by IC and Collaborator, and licensed pursuant to the option of Paragraph 7.2, Collaborator grants to the Government a nonexclusive, nontransferable, irrevocable, paid-up license to practice the CRADA Subject Invention or have the CRADA Subject Invention practiced throughout the world by or on behalf of the Government. In the exercise of this license, the Government will not publicly disclose trade secrets or commercial or financial information that is privileged or confidential within the meaning of 5 U.S.C. § 552(b)(4) or which would be considered privileged or confidential if it had been obtained from a non-federal party.

 

7.5Government License in Collaborator Sole CRADA Subject Inventions. Pursuant to 15 U.S.C. § 3710a(b)(2), for CRADA Subject Inventions made solely by an employee of Collaborator, Collaborator grants to the Government a nonexclusive, nontransferable, irrevocable, paid-up license to practice the CRADA Subject Invention or have the CRADA Subject Invention practiced throughout the world by or on behalf of the Government for research or other Government purposes.

 

7.6Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants an exclusive license to a CRADA Subject Invention made solely by an IC employee or jointly with a Collaborator employee, the Government will retain the right to require Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention in Collaborator’s licensed field of use on terms that are reasonable under the circumstances; or, if Collaborator fails to grant a license, to grant the license itself. The exercise of these rights by the Government will only be in exceptional circumstances and only if the Government determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal regulations, and such requirements are not reasonably satisfied by Collaborator; or (iii) Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this Paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b).

 

7.7Third-Party Rights in IC Sole CRADA Subject Inventions. For a CRADA Subject Invention conceived prior to the Effective Date solely by an IC employee that is first actually reduced to practice after the Effective Date in the performance of the Research Plan, the option offered to Collaborator in Paragraph 7.2 may be restricted if, before the Effective Date, PHS had filed a Patent Application and has either offered or granted a license or has executed a license in the CRADA Subject Invention to a third party. Collaborator nonetheless retains the right to apply for a license to any such CRADA Subject Invention in accordance with the terms and procedures of 35 U.S.C. § 209 and 37 C.F.R. Part 404.

 

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Article 8. Rights of Access and Publication

 

8.1Right of Access to CRADA Data and CRADA Materials. IC and Collaborator agree to exchange all CRADA Data and to share all CRADA Materials. If the CRADA is terminated, both Parties agree to provide CRADA Materials in quantities needed to complete the Research Plan. Such provision will occur before the termination date of the CRADA or sooner, if required by the Research Plan.

 

8.2Use of CRADA Data and CRADA Materials. The Parties will be free to utilize CRADA Data and CRADA Materials internally for their own purposes, consistent with their obligations under this CRADA. The Parties may share CRADA Data or CRADA Materials with their Affiliates, agents or contractors provided the obligations of this Article 8.2 are simultaneously conveyed.

 

(a)CRADA Data.

 

Collaborator and IC will use reasonable efforts to keep CRADA Data confidential until published or until corresponding Patent Applications are filed. To the extent permitted by law, each Party will have the right to use any and all CRADA Data in and for any regulatory filing by or on behalf of the Party.

 

(b)CRADA Materials.

 

Collaborator and IC will use reasonable efforts to keep descriptions of CRADA Materials confidential until published or until corresponding Patent Applications are filed. Collaborator acknowledges that the basic research mission of PHS includes sharing with third parties for further research those research resources made in whole or in part with NIH funding. Consistent with this mission and the tenets articulated in “Sharing of Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts”, December 1999, available at http://www.ott.nih.gov/policy/research_tool.aspx, following publication either Party may make available to third parties for further research those CRADA Materials made jointly by both PHS and Collaborator. Notwithstanding the above, if those joint CRADA Materials are the subject of a pending Patent Application or a Patent, the Parties may agree to restrict distribution or freely distribute them. Either Party may distribute those CRADA Materials made solely by the other Party only upon written consent from that other Party or that other Party’s designee.

 

8.3Confidential Information. Each Party agrees to limit its disclosure of Confidential Information to the amount necessary to carry out the Research Plan, and will place a confidentiality notice on all such information. A Party orally disclosing Confidential Information to the other Party will summarize the disclosure in writing and provide it to the other Party within fifteen (15) days of the disclosure. Each Party receiving Confidential Information agrees to use it only for the purposes described in the Research Plan. Either Party may object to the designation of information as Confidential Information by the other Party.

 

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8.4Protection of Confidential Information. Confidential Information will not be disclosed, copied, reproduced or otherwise made available to any other person or entity without the consent of the owning or providing Party except as required by a court or administrative body of competent jurisdiction, or federal law or regulation. Each Party agrees to use reasonable efforts to maintain the confidentiality of Confidential Information, which will in no instance be less effort than the Party uses to protect its own Confidential Information. Each Party agrees that a Party receiving Confidential Information will not be liable for the disclosure of that portion of the Confidential Information which, after notice to and consultation with the disclosing Party, the receiving Party determines may not be lawfully withheld, provided the disclosing Party has been given a reasonable opportunity to seek a court order to enjoin disclosure.

 

8.5Protection of Human Subjects’ Information. The research and development activities to be conducted under this CRADA are not intended to involve human subjects or human tissues within the meaning of 45 C.F.R. Part 46 and 21 C.F.R. Part 50. Should it become necessary to utilize human subjects or human tissues, or to provide a Party with access to information about identifiable human subjects, the Parties agree to amend this CRADA in accordance with Paragraph 13.6 to ensure that the research and development activities conducted hereunder will conform to the appropriate federal laws and regulations, including but not limited to all applicable FDA regulations and HHS regulations relating to the protection of human subjects.

 

8.6Duration of Confidentiality Obligation. The obligation to maintain the confidentiality of Confidential Information will expire at the earlier of the date when the information is no longer Confidential Information as defined in Paragraph 2.4 or three (3) years after the expiration or termination date of this CRADA. Collaborator may request an extension to this term when necessary to protect Confidential Information relating to products not yet commercialized.

 

8.7Publication. The Parties are encouraged to make publicly available the results of their research and development activities. Before either Party submits a paper or abstract for publication or otherwise intends to publicly disclose information about a CRADA Subject Invention, CRADA Data or CRADA Materials, the other Party will have thirty (30) days to review the proposed publication or disclosure to assure that Confidential Information is protected. Either Party may request in writing that the proposed publication or other disclosure be delayed for up to thirty (30) additional days as necessary to file a Patent Application.

 

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Article 9. Representations and Warranties

 

9.1Representations of IC. IC hereby represents to Collaborator that:

 

(a)IC has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that IC’s official signing this CRADA has authority to do so.

 

(b)To the best of its knowledge and belief, neither IC nor any of its personnel involved in this CRADA is presently subject to debarment or suspension by any agency of the Government which would directly affect its performance of the CRADA. Should IC or any of its personnel involved in this CRADA be debarred or suspended during the term of this CRADA, IC will notify Collaborator within thirty (30) days of receipt of final notice.

 

9.2Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to IC that:

 

(a)Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so.

 

(b)Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or any of its personnel involved in this CRADA be debarred or suspended during the term of this CRADA, Collaborator will notify IC within thirty (30) days of receipt of final notice.

 

(c)Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B, Collaborator is financially able to satisfy these obligations in a timely manner.

 

Article 10. Expiration and Termination

 

10.1Expiration. This CRADA will expire on the last date of the term set forth on the Summary Page. In no case will the term of this CRADA extend beyond the term indicated on the Summary Page unless it is extended in writing in accordance with Paragraph 13.6.

 

10.2Termination by Mutual Consent. IC and Collaborator may terminate this CRADA at any time by mutual written consent.

 

10.3Unilateral Termination. Either IC or Collaborator may unilaterally terminate this CRADA at any time by providing written notice at least sixty (60) days before the desired termination date. IC may, at its option, retain funds transferred to IC before unilateral termination by Collaborator for use in completing the Research Plan.

 

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10.4Funding for IC Personnel. If Collaborator has agreed to provide funding for IC personnel and this CRADA is mutually or unilaterally terminated by Collaborator before its expiration, then Collaborator agrees that funds for that purpose will be available to IC for a period of six (6) months after the termination date or until the expiration date of the CRADA, whichever occurs sooner. If there are insufficient funds to cover this expense, Collaborator agrees to pay the difference.

 

10.5New Commitments. Neither Party will incur new expenses related to this CRADA after expiration, mutual termination, or a notice of a unilateral termination and will, to the extent feasible, cancel all outstanding commitments and contracts by the termination date. Collaborator acknowledges that IC will have the authority to retain and expend any funds for up to one (1) year subsequent to the expiration or termination date to cover any unpaid costs obligated during the term of the CRADA in undertaking the research and development activities set forth in the Research Plan.

 

Article 11. Disputes

 

11.1Settlement. Any dispute arising under this CRADA which is not disposed of by agreement of the Principal Investigators will be submitted jointly to the signatories of this CRADA. If the signatories, or their designees, are unable to jointly resolve the dispute within thirty (30) days after notification thereof, the Assistant Secretary for Health (or his/her designee or successor) will propose a resolution. Nothing in this Paragraph will prevent any Party from pursuing any additional administrative remedies that may be available and, after exhaustion of such administrative remedies, pursuing all available judicial remedies.

 

11.2Continuation of Work. Pending the resolution of any dispute or claim pursuant to this Article 11, the Parties agree that performance of all obligations will be pursued diligently.

 

Article 12. Liability

 

12.1NO WARRANTIES. EXCEPT AS SPECIFICALLY STATED IN ARTICLE 9, THE PARTIES MAKE NO EXPRESS OR IMPLIED WARRANTY AS TO ANY MATTER WHATSOEVER, INCLUDING THE CONDITIONS OF THE RESEARCH OR ANY INVENTION OR MATERIAL, WHETHER TANGIBLE OR INTANGIBLE, MADE OR DEVELOPED UNDER OR OUTSIDE THE SCOPE OF THIS CRADA, OR THE OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE RESEARCH OR ANY INVENTION OR MATERIAL, OR THAT A TECHNOLOGY UTILIZED BY A PARTY IN THE PERFORMANCE OF THE RESEARCH PLAN DOES NOT INFRINGE ANY THIRD-PARTY PATENT RIGHTS.

 

12.2Indemnification and Liability. Collaborator agrees to hold the Government harmless and to indemnify the Government for all liabilities, demands, damages, expenses and losses arising out of the use by Collaborator for any purpose of the CRADA Data, CRADA Materials or CRADA Subject Inventions produced in whole or part by IC employees under this CRADA, unless due to the negligence or willful misconduct of IC, its employees, or agents. The Government has no statutory authority to indemnify Collaborator. Each Party otherwise will be liable for any claims or damages it incurs in connection with this CRADA, except that IC, as an agency of the Government, assumes liability only to the extent provided under the Federal Tort Claims Act , 28 U.S.C. Chapter 171.

 

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12.3Force Majeure. Neither Party will be liable for any unforeseeable event beyond its reasonable control and not caused by its own fault or negligence, which causes the Party to be unable to perform its obligations under this CRADA, and which it has been unable to overcome by the exercise of due diligence. If a force majeure event occurs, the Party unable to perform will promptly notify the other Party. It will use its best efforts to resume performance as quickly as possible and will suspend performance only for such period of time as is necessary as a result of the force majeure event.

 

Article 13. Miscellaneous

 

13.1Governing Law. The construction, validity, performance and effect of this CRADA will be governed by U.S. federal law, as applied by the federal courts in the District of Columbia. If any provision in this CRADA conflicts with or is inconsistent with any U.S. federal law or regulation, then the U.S. federal law or regulation will preempt that provision.

 

13.2Compliance with Law. IC and Collaborator agree that they will comply with, and advise their contractors and agents to comply with, all applicable statutes, Executive Orders, HHS regulations, and all FDA, CDC, and NIH policies relating to research on human subjects (45 C.F.R. Part 46, 21 C.F.R. Parts 50 and 56) and relating to the appropriate care and use of laboratory animals (7 U.S.C. §§ 2131 et seq.; 9 C.F.R. Part 1, Subchapter A). Additional information on these subjects is available from the HHS Office for Human Research Protections or from the NIH Office of Laboratory Animal Welfare. Collaborator agrees to ensure that employees, contractors, and agents of Collaborator who might have access to a “select agent or toxin” (as that term is defined in 42 C.F.R. §§ 73.4-73.5) transferred from IC is properly licensed to receive the “select agent or toxin.”

 

13.3Waivers. None of the provisions of this CRADA will be considered waived by any Party unless a waiver is given in writing to the other Party. The failure of a Party to insist upon strict performance of any of the terms and conditions hereof, or failure or delay to exercise any rights provided herein or by law, will not be deemed a waiver of any rights of any Party.

 

13.4Headings. Titles and headings of the articles and paragraphs of this CRADA are for convenient reference only, do not form a part of this CRADA, and will in no way affect its interpretation.

 

13.5Severability. The illegality or invalidity of any provisions of this CRADA will not impair, affect, or invalidate the other provisions of this CRADA.

 

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13.6Amendments. Minor modifications to the Research Plan may be made by the mutual written consent of the Principal Investigators. Substantial changes to the CRADA, extensions of the term, or any changes to Appendix C will become effective only upon a written amendment signed by the signatories to this CRADA or by their representatives duly authorized to execute an amendment. A change will be considered substantial if it directly expands the range of the potential CRADA Subject Inventions, alters the scope or field of any license option governed by Article 7, or requires a significant increase in the contribution of resources by either Party.

 

13.7Assignment. Neither this CRADA nor any rights or obligations of any Party hereunder shall be assigned or otherwise transferred by either Party without the prior written consent of the other Party. The Collaborator acknowledges the applicability of 41 U.S.C. § 15, the Anti Assignment Act, to this Agreement. The Parties agree that the identity of the Collaborator is material to the performance of this CRADA and that the duties under this CRADA are nondelegable.

 

13.8Notices. All notices pertaining to or required by this CRADA will be in writing, signed by an authorized representative of the notifying Party, and delivered by first class, registered, or certified mail, or by an express/overnight commercial delivery service, prepaid and properly addressed to the other Party at the address designated on the Contacts Information Page, or to any other address designated in writing by the other Party. Notices will be considered timely if received on or before the established deadline date or sent on or before the deadline date as verifiable by U.S. Postal Service postmark or dated receipt from a commercial carrier. Notices regarding the exercise of license options will be made pursuant to Paragraph 7.3. Either Party may change its address by notice given to the other Party in the manner set forth above.

 

13.9Independent Contractors. The relationship of the Parties to this CRADA is that of independent contractors and not agents of each other or joint venturers or partners. Each Party will maintain sole and exclusive control over its personnel and operations.

 

13.10Use of Name; Press Releases. By entering into this CRADA, the Government does not directly or indirectly endorse any product or service that is or will be provided, whether directly or indirectly related to either this CRADA or to any patent or other intellectual- property license or agreement that implements this CRADA by Collaborator, its successors, assignees, or licensees. Collaborator will not in any way state or imply that the Government or any of its organizational units or employees endorses any product or service. Each Party agrees to provide proposed press releases that reference or rely upon the work under this CRADA to the other Party for review and comment at least seven (7) days prior to publication. Either Party may disclose the Summary Page to the public without the approval of the other Party.

 

13.11Reasonable Consent. Whenever a Party’s consent or permission is required under this CRADA, its consent or permission will not be unreasonably withheld.

 

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13.12Export Controls. Collaborator agrees to comply with U.S. export law and regulations. If Collaborator has a need to transfer any CRADA Materials made in whole or in part by IC, or IC Materials, or IC’s Confidential Information, to a person located in a country other than the United States, to an Affiliate organized under the laws of a country other than the United States, or to an employee of Collaborator in the United States who is not a citizen or permanent resident of the United States, Collaborator will acquire any and all necessary export licenses and other appropriate authorizations.

 

13.13Entire Agreement. This CRADA constitutes the entire agreement between the Parties concerning the subject matter of this CRADA and supersedes any prior understanding or written or oral agreement, without limitation, the Confidential Disclosure Agreement executed by the Parties on May 14, 2020 (NCI CDA #15857-20). Upon execution of this CRADA, the CDA is hereby superseded and succeeded by the terms of this CRADA.

 

13.14Survivability. The provisions of Paragraphs 3.3, 3.4, 4.2, 4.3, 5.3, 5.4, 6.1-9.2, 10.3- 10.5, 11.1, 12.1-12.3, 13.1-13.3, 13.10 and 13.14 will survive the expiration or early termination of this CRADA.

 

SIGNATURES BEGIN ON THE NEXT PAGE.

 

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SIGNATURE PAGE

 

ACCEPTED AND AGREED

 

BY EXECUTING THIS AGREEMENT, EACH PARTY REPRESENTS THAT ALL STATEMENTS MADE HEREIN ARE TRUE, COMPLETE, AND ACCURATE TO THE BEST OF ITS KNOWLEDGE. COLLABORATOR ACKNOWLEDGES THAT IT MAY BE SUBJECT TO CRIMINAL, CIVIL, OR ADMINISTRATIVE PENALTIES FOR KNOWINGLY MAKING A FALSE, FICTITIOUS, OR FRAUDULENT STATEMENT OR CLAIM.

 

FOR IC:    
     
/s/ Douglas R. Lowy, M.D.   10/23/20
Signature   Date
     
Douglas R. Lowy, M.D.    
Deputy Director, NCI    

 

FOR COLLABORATOR:    
     
/s/ William V. Williams, M.D.   2020 October 28
Signature   Date
     
William V. Williams, M.D.    
President and CEO    

 

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CONTACTS INFORMATION PAGE

 

CRADA Notices

 

For IC:

Technology Transfer Center

National Cancer Institute

9609 Medical Center Drive

Bethesda, MD 20892-9702 MSC 9702

Rockville, MD 20850-9702 (express mail)

Tel: 240-276-5530/Fax: 240-276-5504

For Collaborator:

William V. Williams, M.D.

BriaCell Therapeutics Corp.

620 South Eagle Road

Havertown, PA 19083

Office: 1- 888-485-6340

Cell: 1- 302-290-9017

Fax: 1- 424-245-3719

Email: williams@BriaCell.com

 

Patenting and Licensing

 

For IC:

Same as above.

For Collaborator (if separate from above):

Same as above.

 

Finances

 

For IC: For Collaborator (if separate from above):
Technology Transfer Manager for Finances Same as above.
NCI, Technology Transfer Center  

9609 Medical Center Dr., 1E-452, MSC 9702

Bethesda, MD 20892-9702

 
Tel: 240-276-5510  
Email: Bonnie.Chamberlain@nih.gov  
EIN: 52-0858115  

 

Delivery of Materials Identified in Appendix B (if any)

 

For IC:

Jay A. Berzofsky, M.D., Ph.D.

Chief, NCI CCR Vaccine Branch

Bldg. 41—Rm D702D (MSC-5062)

National Institutes of Health

41 Medlars Drive

Bethesda, Maryland 20892-5062 USA

Tel: 240-760-6148

Fax: 240-541-4452

Email: berzofsj@mail.nih.gov

 

For Collaborator:

William V. Williams, M.D.

BriaCell Therapeutics Corp.

820 Heinz Avenue

Berkeley, CA 94710

Office: 1- 888-485-6340

Cell: 1- 302-290-9017

Fax: 1- 424-245-3719

Email: williams@BriaCell.com

 

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SUMMARY PAGE

 

EITHER PARTY MAY, WITHOUT FURTHER CONSULTATION OR PERMISSION, RELEASE THIS SUMMARY PAGE TO THE PUBLIC.

 

TITLE OF CRADA: Evaluation of BriaCell Therapeutics Corp.’s proprietary Bria-OTS cellular immunotherapy using dendritic cell lines as vehicles for cancer vaccines
   
   
IC Component: National Cancer Institute
IC Principal Investigator: Jay Berzofsky, M.D., Ph.D.
   
Collaborator: BriaCell Therapeutics Corp.
Collaborator Principal Investigator: William V. Williams, M.D.
   
TERM OF CRADA: Three (3) years from the Effective Date.

 

ABSTRACT OF THE RESEARCH PLAN:

 

The National Cancer Institute and BriaCell Therapeutics Corp. will work together to conduct preclinical studies under a Cooperative Research and Development Agreement (CRADA) to develop and test BriaCell Therapeutic Corp.’s proprietary Bria-OTS cellular immunotherapy as a treatment for cancer to improve and broaden applicability of this therapeutic strategy.

 

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APPENDIX A

 

RESEARCH PLAN

 

GOAL AND SCOPE OF THIS CRADA

 

The principal goal of this CRADA is to evaluate the use of BriaCell Therapeutic Corp.’s (BriaCell) proprietary Bria-OTS cellular immunotherapy as a treatment for cancer to improve and broaden the applicability of this therapeutic strategy. More specifically, using BriaCell’s proprietary Bria-OTS cellular immunotherapy, the NCI Vaccine Branch (VB) and BriaCell researchers will develop and test allogeneic, immortalized mouse and potentially human dendritic cells (DCs) that express select sets of mouse major histocompatibility complex (MHC) or human leukocyte antigen (HLA) alleles to match tumors in mouse models or human patients, respectively.

 

The scope of this CRADA Research Plan, including any in vitro and in vivo testing conducted by Dr. Jay Berzofsky and members of Dr. Berzofsky’s laboratory, is strictly limited to the development of BriaCell’s proprietary Bria-OTS cellular immunotherapy to treat cancer.

 

INTRODUCTION

 

Although there have been major advances in the field of cancer immunotherapy with the approval of sipuleucel-T (PROVENGE®), ipilumumab (YERVOY®), as well as pembrolizumab (KEYTRUDA®), nivolumab (OPDIVO®), and several other immunotherapeutic agents, a significant challenge that remains is the identification and characterization of immunologic responses that correlate with beneficial clinical outcomes and could potentially help stratify patients into predicted responders and non-responders. The reason for the limited success of cancer vaccines appears to be their contravention by immunosuppressive mechanisms such as cytokines, e.g., TGF-beta and IL-10, cell surface checkpoints, e.g., PD-1 and CTLA-4, and by cellular components, e.g., T-regulatory cells, myeloid-derived suppressor cells and regulatory NKT cells to name a few, rather than the absolute lack of immune response to the vaccine target.

 

The Berzofsky laboratory focuses on elucidating new fundamental principles governing T cell activation, regulation, and effector function, and employing these to develop more effective vaccine and immunotherapy strategies for HIV, cancer, and viruses causing cancer. They previously established that an adenovirus vaccine expressing the extracellular and transmembrane domains of HER-2 can cure large established mammary cancers and lung metastases in mice through a mechanism that involves antibodies that inhibit HER-2 function, rather than T cells. Following the publication of these results, they made a similar recombinant adenovirus expressing the human HER-2 domains, which is being investigated clinically in human cancer patients. The vaccine consists of autologous DCs transduced with the Ad-HER2 vector [1].

 

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Autologous DC-based vaccination approaches have shown promise in clinical trials [1-5] but are, however, expensive and labor-intensive. BriaCell researchers have developed a novel class of targeted immunotherapy for patients with metastatic or recurrent breast cancer who have previously failed at least one line of treatment. SV-BR-1-GM is a therapeutic breast cancer cell line that expresses class I and II HLA complex genes. They have successfully demonstrated in a Phase I/IIa clinical trial that SV-BR-1-GM is a safe therapy, and they demonstrated its efficacy by inducing biological response and tumor shrinkage in HLA-matched breast cancer patients. Since only an estimated 47% of the U.S. population matches one or more of the relevant class II HLA alleles expressed in the SV-BR-1-GM cells, four discrete allogeneic cell lines each overexpressing distinct HLA alleles were designed to match over 99% of the U.S. population based on their HLA type. These cell lines, referred to as Bria-OTS™ (off-the-shelf), represent novel therapeutics for use in treatment regimens anticipated to be more effective, less toxic, and with greater impact on long-term survival than current therapies.

 

Unlike other approaches where specific molecules involved in T cell deactivation (e.g., PD-1) are targeted, often resulting in serious immune-related side effects, Bria-OTS cellular immunotherapy uniquely targets specific patient populations based on their immune system and tumor type (i.e., precision treatment). The company’s targeted therapeutic enlists and empowers the patient’s immune system to attack tumors. Thus, once a patient’s HLA signature is known, the necessary Bria-OTS cell line (or a combination of cell lines) that match at least one HLA allele of the patient can be assigned for treatment, and treatment can begin immediately, without the need for patient-specific manufacturing. BriaCell has previously demonstrated that tumor- directed immune responses may occur using allogeneic breast cancer cell lines with properties of antigen-presenting cells (APCs) [6].

 

EXPERTISE OF THE PARTIES

 

  Vaccine Branch, CCR, NCI: The NCI Vaccine Branch has expertise in translating novel anti-cancer vaccines it has developed, from the preclinical research stage to clinical investigation, in order to harness a patient’s own immune system to fight against cancer or chronic infections. Jay A. Berzofsky, M.D., Ph.D., Chief of the Vaccine Branch, and colleagues have expertise in T cell immunology and tumor immunology and translation of basic immunological research to strategies to develop vaccines for cancer, human immunodeficiency virus (HIV), and viruses that cause cancer. The Vaccine Branch Clinical Trials Team is exploring various strategies to broaden cancer treatment options with lower toxicity customized to individual patients.

 

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  BriaCell Therapeutics Corp.: BriaCell Therapeutics Corporation (BriaCell) has experience in drug discovery and drug development from first in human studies through post-approval and marketing. William V. Williams, M.D., President and CEO, and Markus Lacher, Ph.D., Head of Research and Development, have expertise in immunology, molecular biology, clinical pharmacology, drug development, cellular therapies, pharmacodynamic marker development and validation. Together they have over 40 years of experience in these fields and over 150 scientific publications, over 30 successful Investigational New Drug (IND) applications and over 10 successful New Drug Applications. BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer. BriaCell is focused on the development of cellular immunotherapies utilizing cell lines that can induce potent and selective anti-cancer immune responses.
     
  Jointly: The NCI Vaccine Branch and BriaCell will utilize their combined expertise to design experiments and develop reagents which will permit delineation of the importance of MHC matching in the efficacy of cellular immunotherapies for cancer. They will specifically use their expertise in tumor immunology, molecular biology and development of cellular therapies to design murine experiments which will illuminate the relevant immunologic pathways necessary to develop an effective immune response against cancer. This will lead to the development of novel human therapeutics which could be the subject of future clinical collaborations.

 

EXPERIMENTAL PLAN

 

The experimental details that follow are approximate and may be changed upon mutual agreement of the NCI and Collaborator. Any substantive change to the Research Plan will be by mutual agreement and written Amendment to this CRADA.

 

Whereas BriaCell’s approach with an irradiated, human breast cancer cell line (SV-BR-1-GM) with properties of antigen-presenting cells (APCs) [6] has shown tumor regressions in advanced breast cancer patients with HLA match(es) to the cell line, the approach is not optimized as SV- BR-1-GM does not show all critical features of APCs including expression of co-stimulatory molecules such as CD80 or CD86. Therefore, the NCI and BriaCell researchers will optimize the strategy by engineering cell lines representing bona fide DCs. This project is aimed at establishing proof-of-concept data in a mouse model. Positive data would then serve as supporting information for an investigational drug application (IND) for a clinical study in solid tumors.

 

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The researchers propose to develop a mouse model of this therapeutic strategy in which a mouse DC line is used either unmodified or modified with additional MHC alleles or other immunostimulatory molecules. This mouse DC line can be transduced with the mouse Ad-HER2 vector or pulsed with peptides from tumor antigens of other mouse tumors. By using mice that differ in only one class I or one class II MHC allele or all of the MHC, the researchers will examine the ability of these DCs that are partially matched or fully allogeneic to present antigen in vitro and to induce anti-tumor immunity in vivo in mice. The approaches developed can then be translated to the human equivalent in the clinic.

 

The NCI and BriaCell researchers envision two projects, of which the second is optional and may only be conducted pending the results of the first project and if factors such as the availability of sufficient funds are in place and the mutual agreement of the Parties.

 

In the first project, immune activation and functional links between the MHC type of a murine DC line (DC2.4) expressing GM-CSF in mice will be assessed. Initially, the researchers will use the DC2.4 mouse DC line from Millipore-Sigma and modify that as needed. DC2.4 cells are immortalized murine DCs created by transducing bone marrow isolates of C57BL/6 mice with retrovirus vectors expressing murine granulocyte-macrophage CSF (GM-CSF) and the myc and raf oncogenes. DC2.4 exhibits characteristic features of DCs including cell morphology, the expression of DC-specific markers, and the ability to phagocytose and present exogenous antigens on both MHC I and II molecules (from product Data Sheet).

 

  DC2.4 cells will be engineered to express either i) MHC Class Ia, K: bm3, ii) MHC Class II, A: bm12, or iii) MHC Class Ia, K: bm3 and MHC Class II, A: bm12. DC2.4 cells with the bm3 and bm12 modifications as well as unmodified DC2.4 cells will be irradiated (to prevent in vivo replication), pulsed with antigenic peptides, then inoculated into mice with and without MHC matches to the cell lines. Spleens and PBMCs of inoculated animals will be harvested, splenic DCs will be isolated using CD11c beads, pulsed with the antigenic peptides, then used as target cells for cytotoxicity experiments using splenic T cells as effector cells. The Parties hypothesize that the highest level of cytotoxicity will be achieved in the absence of MHC mismatch (i.e., with MHC match).
     
  To assess whether MHC match/mismatch between the DC2.4 vaccine cells affects therapeutic efficacy in a mouse model, C57BL/6 mice will be inoculated with B16 tumor cells (DC2.4 and B16 cells are syngeneic with C57BL/6 mice). Once tumors are established, unmodified and MHC-modified DC2.4 cells will be irradiated, pulsed with peptides representing antigens expressed in B16 cells (i.e., gp100), and inoculated into the tumor-bearing mice. The Parties hypothesize that the highest degree of tumor shrinkage will be achieved in the absence of MHC mismatch (i.e., with MHC match).

 

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Support of the hypotheses stated for the first project would indicate support for an IND application package. Assuming the availability of sufficient financial resources and the mutual agreement of the Parties, the researchers will conduct a second project in which human leukemic cell lines with features of DC lines will be HLA-engineered to match a high percentage of patients. IND-enabling in vitro studies will be conducted.

 

DESCRIPTION OF THE CONTRIBUTIONS AND RESPONSIBILITIES OF THE PARTIES

 

VACCINE BRANCH (VB)/CCR/NCI

 

NCI VB will provide:

 

  Expertise in mouse models of cancer and immune regulatory mechanisms in cancer, as well as cancer vaccines.
  Laboratory and animal facilities, reagents and other materials to carry out the experiments described.
  Use of NCI Core facilities including the Vaccine Branch Flow Cytometry Core.

 

COLLABORATOR

Collaborator will provide:

 

  Expertise in cellular immunotherapy.
  Laboratory facilities, cell lines, reagents and other materials necessary for the studies.

 

COLLABORATOR AND VB/CCR/NCI

 

Jointly NCI VB and Collaborator will work together to conduct the planned research and publish the results of the studies conducted under this CRADA in peer-reviewed scientific journals.

 

RELATED NCI AND COLLABORATOR AGREEMENTS

 

NCI/BriaCell Confidential Disclosure Agreement (NCI Reference #15857-20, effective 05/14/2020). Upon execution of this CRADA, the CDA is hereby superseded and succeeded by the terms of this CRADA.

 

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RELATED INTELLECTUAL PROPERTY OF THE PARTIES

 

Collaborator Patents and Patent Applications:

 

PATENT/ APPL. NO.   PRIORITY DATE   TITLE
U.S. Patent No. 7,674,456 B2   14-June-2004   BREAST CANCER CELL LINES AND USES THEREOF
PCT/US2017/ 019757  

25-Feb-2016/

21-Nov-2016

  WHOLE-CELL CANCER VACCINES AND METHODS FOR SELECTION THEREOF
U.S. Prov. Appl. No. 63/008,456   9-Apr-2020   INDUCING IMMUNE RESPONSES BY TRANSFORMING CANCER CELLS INTO ANTIGEN-PRESENTING CELLS
U.S. Prov. Appl. No. 63/012,840   20-Apr-2020   COMPUTER-GUIDED DESIGN OF ANTIBODIES INCLUDING NEUTRALIZING SARS-CoV-2 BINDING AGENTS
U.S. Prov. Appl. No. 63/014,536   23-Apr-2020   METHODS FOR INDUCING AND ENHANCING ANTI-CANCER IMMUNE RESPONSES USING NOVEL MOLECULAR CONSTRUCTS
U.S. Prov. Appl. No. 63/025,512   15-May-2020   MULTI-VALENT IMMUNOSTIMULATORS FOR INFECTIOUS DISEASES, AUTOIMMUNE DISEASES, ALLERGIC DISEASES AND CANCER
U.S. Prov. Appl. No. 63/042,243   22-Jun-2020   MULTI-VALENT DECOY RECEPTORS FOR DIAGNOSIS AND/OR TREATMENT OF CORONAVIRUS INFECTION

 

NCI Patents and Patent Applications

 

“Compositions and Methods for Treatment of HER2-Expressing Solid Tumors.” U.S. Provisional Application #62/248,964 filed October 30, 2015. PCT Application PCT/US2016/059680 filed October 31, 2016 (NIH Reference No. E-187-2015/0-PCT-02).

 

All continuing (including continuation and divisional), continuation-in-part, and reissue applications, foreign counterpart applications, and extensions of applications that are directed to the subject matter as is disclosed in the above NCI Patents and Patent Applications.

 

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REFERENCES

 

1. Maeng, H.M. and J.A. Berzofsky, Strategies for developing and optimizing cancer vaccines. F1000Res, 2019. 8.
2. Wood, L.V., et al., TARP vaccination is associated with slowing in PSA velocity and decreasing tumor growth rates in patients with Stage D0 prostate cancer. Oncoimmunology, 2016. 5(8): p. e1197459.
3. Castiello, L., et al., Expression of CD14, IL10, and Tolerogenic Signature in Dendritic Cells Inversely Correlate with Clinical and Immunologic Response to TARP Vaccination in Prostate Cancer Patients. Clin Cancer Res, 2017. 23(13): p. 3352-3364.
4. Cheever, M.A. and C.S. Higano, PROVENGE (Sipuleucel-T) in prostate cancer: the first FDA-approved therapeutic cancer vaccine. Clin Cancer Res, 2011. 17(11): p. 3520-6.
5. Skachkova, O.V., et al., Immunological markers of anti-tumor dendritic cells vaccine efficiency in patients with non-small cell lung cancer. Exp Oncol, 2013. 35(2): p. 109-13.
6. Lacher, M.D., et al., SV-BR-1-GM, a Clinically Effective GM-CSF-Secreting Breast Cancer Cell Line, Expresses an Immune Signature and Directly Activates CD4(+) T Lymphocytes. Front Immunol, 2018. 9: p. 776.

 

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APPENDIX B

 

STAFFING, FUNDING AND MATERIALS/EQUIPMENT CONTRIBUTIONS OF THE PARTIES

 

Staffing Contributions

 

IC will provide scientific staff and other support necessary to conduct the research and other activities described in the Research Plan. IC’s scientific staff will include IC’s Principal Investigator and technical staff.

 

IC estimates that 1.3 person-years of effort per year will be required to complete the CRADA research.

 

Collaborator will provide scientific staff and other support necessary to conduct the research and other activities described in the Research Plan. Collaborator’s scientific staff will include Collaborator’s Principal Investigator and technical staff.

 

Collaborator estimates that 1.0 person-years of effort per year will be required to complete the CRADA research.

 

Funding Contributions

 

Collaborator agrees to provide a total of $433,400 to support this project. Collaborator will provide $394,000 over 3 years for IC to use to acquire technical, statistical, and administrative support for the research activities, as well as to pay for supplies and travel expenses and Collaborator will provide a one time, non-refundable payment of $39,400 for NCI CCR infrastructure costs. Except for CCR infrastructure funds, Collaborator agrees that IC can allocate the funding between the various categories in support of the CRADA research.

 

Funds will be due as follows: the first installment of $169,400, including the NCI CCR infrastructure charge, will be due within ninety (90) days of the Effective Date. Each subsequent installment of $132,000 will be due within thirty (30) days of each anniversary of the Effective Date.

 

CRADA PAYMENTS:

 

Collaborator has three options for making CRADA payments. See CRADA Payment Options at http://ttc.nci.nih.gov/forms/crada.php for specific information on making payments using each option.

 

Option 1: Collaborator sends checks to the NCI.

Option 2: Collaborator makes payments via wire transfer.

Option 3: Collaborator makes payments using www.pay.gov.

 

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The NCI TTC does not use a Collaborator’s payment portal or online/electronic invoicing system. If a Collaborator has any questions regarding NCI TTC’s use of such systems, the Collaborator’s financial contact must discuss the situation with NCI TTC’s financial contact well in advance of any need (see the Contacts Information Page of this CRADA).

 

CRADA TRAVEL PAYMENTS:

 

Travel arrangements for all Government staff will be made in accordance with the Federal Travel Rules and Regulations, whether arranged by IC and funded using either appropriated funds or CRADA funds, or arranged and funded directly by Collaborator.

 

Materials/Equipment Contributions

 

IC will provide to the Collaborator the following IC Materials for use under this CRADA: NONE

 

Collaborator will provide to the IC the following Collaborator Materials and/or capital equipment for use under this CRADA:

 

Collaborator Materials: Cell lines, reagents and other materials necessary for the studies.

 

Capital Equipment: NONE

 

If either Party decides to provide additional Materials for use under this CRADA, those Materials will be transferred under a cover letter that identifies them and states that they are being provided under the terms of the CRADA.

 

PHS CRADA

Page 27 of 27

Agreement Ref. No. 03363

Confidential

MODEL ADOPTED June 18, 2009

Revised August 1, 2012

 

 

EX-10.45 7 ex10-45.htm

 

Exhibit 10.45

 

SUBSCRIPTION AGREEMENT FOR DEBENTURE UNITS

(For U.S. Subscribers)

 

BRIACELL THERAPEUTICS CORP.

 

HAVE YOU COMPLETED THIS SUBSCRIPTION AGREEMENT PROPERLY?

The following items in this Subscription Agreement must be completed. (Please initial each applicable box.)

 

All Subscribers
    Complete all Subscriber information in the boxes on page 2
 
Subscribers resident in the United States
    Schedule A and Appendix 1 and 2 thereto, indicating which category (if any) is applicable.
     
Subscribers that are not individuals, if applicable
 

 

 

Schedule C indicating which category (if any) is applicable, together with the TSX Venture Exchange Form 4C
 

 

A completed and executed copy of this Subscription Agreement, including all applicable schedules, must be delivered to:

 

Garfinkle Biderman LLP

1 Adelaide St E, Suite 801

Toronto, ON M5C 1J4

Attention: Shimmy Posen

Fax No: 416-869-0547

E-mail: sposen@garfinkle.com

 

 

METHOD OF PAYMENT

 

Provide payment of the purchase price in Canadian dollars by delivering a certified cheque, money order or bank draft made payable to “Bennett Jones LLP in trust for BriaCell Therapeutics Corp.” or by wire to Bennett Jones LLP in trust for BriaCell Therapeutics Corp. at:

 

Name & Address of Beneficiary:

Bennett Jones LLP, in trust

3400 One First Canadian Place P.O. Box 130

Toronto, ON M5X 1A4

Name & Address of Beneficiary’s Bank:

Royal Bank of Canada

20 King Street West

Toronto, Ontario M5H 1C4

Beneficiary’s Account Number: 1161090
Reference: C. Travascio and J. Lewis – File # 073530.28
ABA/Routing Number Code: 021 000 021
Bank ID 003
SWIFT CODE: ROYCCAT2

 

 
2

 

BRIACELL THERAPEUTICS CORP.
SUBSCRIPTION AGREEMENT
 

TO:

BRIACELL THERAPEUTICS CORP. (the “Corporation”)

 

The undersigned (the “Subscriber”), on its own behalf, hereby irrevocably subscribes for and agrees to purchase from the Corporation an unsecured convertible debenture unit of the Corporation (the “Debenture Unit”) at a purchase price of $375,000 per Debenture Unit (the “Subscription Amount”) less the original discount of approximately 29.33%, subject to the terms and conditions set forth in the attached “Terms and Conditions of Subscription for Debenture and Warrants” (the “Terms and Conditions”, and together with this page and the attached schedules, the “Subscription Agreement”).

 

 

Purchase Price: $265,000

(the “Subscription Amount”) (Principal Amount less the original issuance discount of approximately 29.33%)

 

Account Registration Information: Same as Subscriber Information [  ] or

    (Name)
     
Aggregate Principal Amount: $375,000     
  (Account Reference, if applicable)
     
     
Subscriber Information:   (Address, including Postal Code) (Telephone Number)
     
(Name of Subscriber)   Additional Subscriber Information:
     
Account Reference (if applicable):____________________   1. Number and kind of securities of the Issuer held, directly or indirectly, if any:
     

By:  
  Authorized Signature  

 

     
   
   

2.State whether Subscriber is an Insider of the Issuer:

 

    Yes [   ]     No [  ]

     
(Official Capacity or Title – if the Subscriber is not an individual)    
     
     
(Name of individual whose signature appears above if different than the name of the Subscriber printed above.)   Name of Principal
     
    Principal’s Address
(Subscriber’s Address, including Municipality and Province)    
     
    City/Town                      Province                            Postal Code
     
     
(Telephone Number)                           (Email Address)   Principal’s Telephone Number -OR- E-mail Address

 

 
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ACCEPTANCE: The Corporation hereby accepts the subscription as set forth above on the terms and conditions contained in this Subscription this day of November, 2020.

 

  BRIACELL THERAPEUTICS CORP.
     
  Per:  
    Authorized Signatory

 

 
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TERMS AND CONDITIONS OF SUBSCRIPTION FOR DEBENTURE AND WARRANTS

 

1.Subscription for the Debenture and Warrants. The Subscriber, on its own behalf, hereby tenders to the Corporation this Subscription Agreement which, upon acceptance by the Corporation, will constitute an irrevocable agreement of the Subscriber to purchase from the Corporation and, of the Corporation to issue and sell to the Subscriber the Debenture Unit, all on and subject to the terms and conditions set out in this Subscription Agreement, for the Subscription Amount, which is payable as described in Sections 4 and 5 hereto (the offer, issue and sale of the Debenture and Warrants, the “Offering”).

 

(a)The Debenture Unit is comprised of (i) $375,000 principal amount (“Principal Amount”) of a 5% convertible unsecured debenture of the Corporation (the “Debenture”), due on the Maturity Date (as defined herein), and such Principal Amount having a purchase price of $265,000 after being reduced by an original issuance discount equal to approximately 29.33%; and (ii) 69,188 common share purchase warrants of the Corporation (“Warrants”). Each Debenture is convertible, at the option of the holder, from the period beginning on the date that is six (6) months following the Closing Date, until the repayment of the Debenture in full, into that number of common shares of the Corporation (“Common Shares”) computed on the basis of the principal amount of the Debentures divided by the conversion price of C$5.42 per Common Share (the “Conversion Price”). Each Warrant entitles the holder thereof to purchase one Common Share of the Corporation (each a “Warrant Share”) for a period of five (5) years from the Closing Date at a price of C$5.42 per Warrant Share subject to adjustment as set forth in the Warrants. Each Warrant may also be exercised by presentation and surrender of the Warrant to the Corporation with a written notice of the Subscriber’s intention to effect a cashless exercise, including a calculation of the number of Common Shares to be issued upon such exercise in accordance with the terms of the Warrant certificate (a “Cashless Exercise”). In the event of a Cashless Exercise, in lieu of paying the exercise price in cash, the holder shall surrender the Warrant for that number of Common Shares equal to the quotient obtained by dividing [(A-B) (X)] by (A), where:

 

A = the volume weighted average trading price of the Common Shares on the TSX Venture Exchange or if the Common Shares are not then listed on the TSX Venture Exchange, on such other Canadian stock exchange as may be selected by the directors of the Corporation for such purpose or, if the Common Shares are not then listed on any Canadian stock exchange, in the over-the-counter market, for the one (1) day period ending on the trading day immediately preceding the date on which Warrantholder elects to exercise this Warrant Certificate by means of a “cashless exercise,” as set forth in the applicable subscription form substantially in the form attached as Schedule A;

 

B = the Exercise Price of this Warrant Certificate, as adjusted hereunder; and

 

X = the number of Common Shares that would be issuable upon exercise of this Warrant Certificate in accordance with the terms of this Warrant Certificate if such exercise were by means of a cash exercise rather than a cashless exercise.

 

Upon payment of the Subscription Amount, the Subscriber will receive a Debenture Unit comprised of (i) the Debenture and (ii) 69,188 Warrants. The description of the Debenture Unit, Debentures and the Warrants in this Subscription Agreement is a summary only and is subject to the detailed provisions of the certificates representing the Debentures and the Warrants.

 

 
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2.Definitions. In this Subscription Agreement, unless the context otherwise requires:

 

(a)Accredited Investor Certificate” means the Accredited Investor Certificate in the form attached hereto as Schedule A which is required to be completed by a Subscriber who is a resident of the United States;

 

(b)affiliate” means with respect to another issuer, an issuer if one of them is the subsidiary of the other, or each of them is controlled by the same person;

 

(c)Applicable Securities Laws” means, collectively, the applicable securities laws of the relevant jurisdictions, the regulations, rules, rulings and orders made thereunder, the applicable policy statements issued by the securities regulators thereunder, the securities legislation and policies of each other relevant jurisdiction and the rules of the relevant stock exchange, in each case in effect from time to time;

 

(d)Business Day” means any day other than a Saturday, Sunday or any other day on which principal chartered banks located in the City of Toronto are not open for business;

 

(e)Conversion Price” means, subject to adjustment as provided in the Debenture, $5.42 per Common Share.

 

(f)Closing” means the completion of the issue and sale by the Corporation and the purchase by the Subscribers of the Debentures and Warrants pursuant to the subscription agreements, in the form of this Subscription Agreement, completed by Subscribers;

 

(g)Closing Date” has the meaning ascribed thereto in Section 7;

 

(h)Closing Time” means 1:00 p.m. (Toronto time) on the Closing Date or such other time as the Corporation may determine;

 

(i)Common Shares” means common shares in the capital of the Corporation;

 

(j)Designated Provinces” means each of the provinces of Canada;

 

(k)Disclosed Principal” mean a principal for whom the Subscriber is purchasing as disclosed on the face page of this Subscription Agreement;

 

(l)distribution” and “insider” have the respective meanings ascribed to them in the Securities Act (Ontario);

 

(m)Event of Default” has the meaning ascribed thereto in Schedule “E” attached hereto;

 

(n)International Jurisdiction” has the meaning ascribed thereto in Section 9(e);

 

(o)material” means material in relation to the Corporation and its subsidiaries, considered on a consolidated basis;

 

(p)Maturity Date” means the earlier of (i) November 13, 2025; (ii) the date the Corporation completes a Qualified Financing; or (iii) , or (iii) such earlier date as the principal amount hereof may become due, subject to and in accordance with the terms, conditions and provisions hereof;

 

(q)NI 45-106” means National Instrument 45-106 - Prospectus Exemptions;

 

(r)Offered Securities” any equity or voting securities, or securities convertible into or exchangeable for equity or voting securities, of the Corporation;

 

 
6

 

(s)person” includes an individual, a corporation, a partnership, trust, fund and an association, syndicate, organization or other organized group of persons, whether incorporated or not and an individual or other person in that person’s capacity as a trustee, executor, administrator or personal or other legal representative;

 

(a)Personal Information” means any information about a person (whether an individual or otherwise) and includes information contained in this Subscription Agreement, including the schedules incorporated by reference herein;

 

(t)Qualified Financing” means the sale by the Corporation of $2,000,000 or more of Offered Securities in the aggregate, in one or more closings or tranches.

 

(u)Securities Commissions” means, collectively, the applicable securities commission or other securities regulatory authority in each of the Designated Provinces, the United States or in any International Jurisdiction;

 

(v)Subscriber” means a subscriber for Debentures and “Subscribers” means all subscribers for the Debentures including the Subscriber;

 

(w)Subscription Amount” means the aggregate subscription amount for Debentures as more particularly set forth on the face page hereof, subscribed for and paid for pursuant to this Subscription Agreement;

 

(x)Term Sheet” means the term sheet attached hereto as Schedule D;

 

(y)United States” or “U.S.” means the United States of America, its territories and possessions, and any state of the United States and the District of Columbia;

 

(z)U.S. Person” shall have the meaning ascribed to such term in Rule 902(k) of Regulation S under the U.S. Securities Act;

 

(aa)U.S. Securities Act” means the United States Securities Act of 1933, as amended;

 

(bb)Warrants” has the meaning ascribed thereto in Section 1 hereof; and

 

(cc)Warrant Shares” has the meaning ascribed thereto in Section 1 hereof.

 

3.Description of Offering.

 

(a)The Debenture Unit is comprised of the Debenture and the Warrants;

 

(b)The Debenture is an unsecured convertible debenture and shall evidence indebtedness of the Corporation to the holder thereof in the principal amount stated on the Debenture certificate and such principal amount shall be equal to the Principal Amount.

 

(c)Interest shall accrue on the Principal Amount at a rate of 5% per annum, increasing to 12% per annum upon an Event Of Default (as such term is defined in the Debenture, attached hereto as Schedule “E”) until the Event of Default is cured, in Canadian dollars, with interest to be paid annually in cash in arrears on each anniversary of the Closing Date, until the Principal Amount is paid off in full.

 

(d)The Debenture shall be convertible into Common Shares, in whole or in part, at the option of the Debenture holder, at the Conversion Price, during the period beginning six (6) months after the Closing Date and ending upon the repayment of the Debenture in full.

 

 
7

 

(e)The Corporation may prepay any amount of the Principal Amount of the Debenture during the initial 120 day period after the Closing Date without penalty. After 120 days following the Closing Date, if the Corporation elects to prepay the Debenture prior to November 13, 2021, an additional prepayment penalty equal to 35% of the Principal Amount of the Debenture is required to be paid by the Corporation (“Penalty Payment”). The Payment Penalty will be satisfied by the Corporation in cash, and the Corporation shall not under any circumstances satisfy the Penalty Payment with the issuance of common shares.

 

(f)If there is an Event of Default, the Debenture may be converted into Common Shares at the Conversion Price at the option of the Debenture holder, and an additional penalty equal to 40% of the Principal Amount of the Debenture is required to be paid by the Corporation (the “Default Payment Penalty”). The Default Payment Penalty, if applicable, will be satisfied by the Corporation in cash, and the Corporation shall not under any circumstances satisfy the Default Penalty Payment with the issuance of common shares.

 

(g)The description of the Debenture in this Subscription Agreement is a summary only and is subject to the detailed provisions of the certificates representing the Debenture pursuant to which such Debenture is to be issued.

 

(h)The Warrants entitle the holder thereof to purchase up to 69,188 Warrant Shares of the Corporation for a period of five (5) years from the Closing Date at a price of C$5.42 per Warrant Share (subject to adjustment in certain circumstances).

 

(i)The description of the Warrants in this Subscription Agreement is a summary only and is subject to the detailed provisions of the certificates representing the Warrants pursuant to which such Warrants are to be issued.

 

4.Delivery and Payment. The Subscriber agrees that the following shall be delivered to Bennett Jones LLP, 3400 One First Canadian Place, P.O. Box 130, Toronto, ON, M5X 1A4, not later than 4:00 p.m. (Toronto Time) Attention: Jessie Lewis Fax No: 416-863-1716 E-mail: LewisJ@bennettjones.com, not later than 4:00 p.m. (Toronto Time) on the day that is not less than one business day prior to the Closing Date or such other date or place as the Corporation may advise:

 

(a)a completed and duly signed copy of this Subscription Agreement;

 

(b)a duly completed Schedule “A” – the United States Accredited Investor Representation Letter, including Appendix “1” and, if applicable, Appendix “2”, to the Schedule “A” – the Form of U.S. Accredited Investor Status Certificate

 

(c)if you are not an individual, Schedule C and if applicable Form 4C of the TSX Venture Exchange contained therein;

 

(d)a duly completed Form 2A of the TSX Venture Exchange, located at: https://www.tmx.com/pif;

 

(e)any other documents required by applicable Securities Laws which the Corporation may request; and

 

(f)the aggregate Subscription Amount payable by the Subscriber for the Subscriber’s Debenture Unit subscribed for under this Subscription Agreement, paid by a certified cheque or bank draft drawn on a Canadian chartered bank made payable to “Bennett Jones LLP in trust for BriaCell Therapeutics Corp.”, or by wire transfer to Bennett Jones LLP in trust for paid by wire transfer to BriaCell Therapeutics Corp. pursuant to the wiring instructions set out on the cover page.

 

 
8

 

The Subscriber acknowledges and agrees that such documents, when executed and delivered by the Subscriber, will form part of and will be incorporated into this Subscription Agreement and each shall constitute a representation and warranty or covenant of the Subscriber hereunder in favour of the Corporation. The Subscriber consents to the filing of such documents as may be required to be filed with any securities regulatory authority in connection with the transactions contemplated hereby. Subject to the terms and conditions contained in this Subscription Agreement, the Subscriber acknowledges and agrees that this offer, the aggregate Subscription Amount and any other documents delivered in connection herewith will be held by the Corporation’s counsel, in trust, until such time as the conditions set out in this Subscription Agreement are satisfied by the Corporation.

 

5.Closing. The transactions contemplated hereby will be completed at the Closing at the offices of Bennett Jones LLP, 3400 One First Canadian Place, P.O. Box 130, Toronto, ON, M5X 1A4 at the Closing Time.

 

If, at the Closing Time, the terms and conditions contained in this Subscription Agreement have been complied with to the satisfaction of the Corporation, or waived by the Corporation, the Corporation, upon receipt of all completed and executed Subscription Agreements in respect of the Offering and the aggregate subscription proceeds in respect of the Offering, will deliver or cause to be delivered to the Subscriber certificates evidencing ownership of the Debenture and Warrants so purchased, and such other documentation and securities as may be required pursuant to this Subscription Agreement.

 

If, prior to the Closing Time, the terms and conditions contained in this Subscription Agreement (other than delivery by the Corporation to the Subscriber of the Debenture and Warrants), have not been complied with to the satisfaction of the Corporation, or waived by it, the Corporation and the Subscriber will have no further obligations under this Subscription Agreement.

 

6.Representations, Warranties and Covenants of the Corporation. The Corporation represents and warrants to, and covenants with the Subscriber that, except as set out expressly in any specific subsection below, as of the date of this Subscription Agreement;

 

(a)the Corporation is a valid and subsisting corporation duly organized and in good standing under the laws of the Province of British Columbia;

 

(b)the Corporation has full power and authority to enter into and perform this Subscription Agreement and to do all other acts which are necessary to consummate the transactions contemplated in the Subscription Agreement;

 

(c)the Corporation is a “reporting issuer” in British Columbia and Alberta and the Common Shares are listed and posted for trading on the TSX Venture Exchange;

 

(d)no order ceasing or suspending trading in the securities of the Corporation nor prohibiting sale of such securities has been issued to the Corporation or its directors, officers or promoters and, to the knowledge of the Corporation, no investigations or proceedings for such purposes are pending or threatened;

 

(e)the Corporation has complied and will fully comply with the requirements of applicable securities and corporate legislation in respect of the Offering;

 

(f)the issuance and sale of the Debenture and Warrants does not and will not conflict with and does not and will not result in a breach of any of the terms, conditions, or provisions of the constating documents of the Corporation or any agreement or instrument to which the Corporation is a party or by which its assets are affected;

 

 
9

 

(g)this Subscription Agreement has been or will be at the Closing, duly authorized by all necessary corporate action on the part of the Corporation, and constitutes a valid obligation of the Corporation legally binding upon it and enforceable against the Corporation in accordance with its terms subject to applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting the enforcement of creditors’ rights generally and as limited by laws relating to the availability of equitable remedies;

 

(h)the Common Shares and Warrant Shares, upon payment in full therefor, will, at the time of issue, be duly allotted, validly issued, fully paid and non-assessable and will be free of all liens, charges and encumbrances;

 

(i)on the Closing, the approvals from the TSX Venture Exchange that are required for the transactions herein contemplated to occur at Closing will have been obtained other than any post-Closing filings required by the TSX Venture Exchange or under applicable Securities Laws; and

 

(j)The Corporation covenants and agrees that if, at any time prior to the Maturity Date, the Corporation proposes to file a registration statement with respect to any class of equity or equity-related securities (other than in connection with an offering to the Corporation’s employees (e.g., Form S-8), or in connection with an acquisition, merger or similar transaction (e.g., Form S-4), under the U.S. Securities Act in a primary registration on behalf of the Corporation and/or in a secondary registration on behalf of holders of such securities, and the registration form to be used may be used for the resale of the Common Shares, the Corporation will include such Common Shares (i) not previously sold or transferred by the Subscriber (i.e., held by the original Subscriber); or (ii) not otherwise able to be freely sold by the Subscriber pursuant to the requirements of Rule 144 of the U.S. Securities Act (such remaining Common Shares, the “Registrable Securities”), in such registration statement or give prompt written notice to the Subscriber of its intention to file a registration statement and will offer to include in such registration statement, such number of Registrable Securities with respect to which the Subscriber has received written requests for inclusion therein within twenty (20) days after the giving of notice by Corporation (the “Piggyback Registration Rights”). The Subscriber acknowledges and understands that the Corporation may file a primary or secondary registration on behalf of certain investors that have provided or will provide financing or other resources to the Corporation, that the inclusion of the Registrable Securities in such registration is subject to the prior approval of such investors, and that such investors may not approve the inclusion of the Registrable Securities, in which case, the Piggyback Registration Rights provided in this paragraph will continue pursuant to the terms of this paragraph for any subsequent primary or secondary registration. The Subscriber also agrees that the Corporation may be limited in its ability to register all of the Registrable Securities on a single registration statement pursuant to Rule 415 of the U.S. Securities Act and consents and agrees to the Corporation registering less than all of the Registrable Securities in the event the Corporation is precluded from registering all of the Registrable Securities pursuant to Rule 415 (or any other rule or regulation promulgated by the Securities and Exchange Commission). Notwithstanding the requirements of this Section (j), the Piggyback Registration Rights shall not apply to offerings by the Corporation on Form S-3 (or pursuant to prospectus supplements filed to Form S-3’s), unless the Corporation files a resale registration on Form S-3.

 

 
10

 

7.Conditions and Closing. The Closing shall occur on or before November 13, 2020, or on such other date as may be determined by the Corporation (the “Closing Date”).

 

The Closing (including the closing of this Subscription) is conditional upon and subject to:

 

(a)payment by the Subscriber (in form acceptable to the Corporation) of the Subscription Amount in immediately available funds;

 

(b)the Subscriber having properly completed, signed and delivered to the Corporation this Subscription Agreement, including any applicable Schedules, and all other documentation contemplated by this Subscription Agreement;

 

(c)the Corporation accepting the Subscriber’s subscription, in whole or in part;

 

(d)the Corporation having obtained all necessary approvals and consents, including regulatory approvals and approvals from the TSX Venture Exchange for the Offering;

 

(e)the Corporation having obtained approval of the terms of the Offering from a majority of the disinterested shareholders of the Corporation;

 

(f)the issue and sale of the Debenture and Warrants being exempt from the requirement to file a prospectus or deliver an offering memorandum (as defined in Applicable Securities Laws, including Ontario Securities Commission Rule 14-501 - Definitions) and the requirement to deliver an offering memorandum under Applicable Securities Laws relating to the sale of the Debenture and the Warrants, or the Corporation having received such orders, consents or approvals as may be required to permit such sale without the requirement to file a prospectus or deliver an offering memorandum; and

 

(g)the representations and warranties of the Subscriber being true and correct as at the Closing Time.

 

The Subscriber acknowledges and agrees that as the sale of the Subscriber’s Debenture and Warrants will not be qualified by a prospectus, such sale is subject to the condition that the Subscriber (or, if applicable, any others for whom the Subscriber is contracting hereunder) sign and return to the Corporation all relevant documentation required by Applicable Securities Laws.

 

8.Acceptance or Rejection. The Corporation will have the right to accept or reject this subscription in whole or in part at any time at any time at or prior to the Closing Time. The Subscriber acknowledges and agrees that the acceptance of this subscription will be conditional upon the issue and sale of the Debenture and Warrants to the Subscriber and the Common Shares and Warrant Shares underlying such Debenture and Warrants, respectively, being exempt from any requirement to file a prospectus or offering memorandum or any similar document under Applicable Securities Laws. The Corporation will be deemed to have accepted this subscription upon the Corporation’s execution of the acceptance form at the beginning of this Subscription Agreement and the delivery at the Closing of the certificate or evidence of electronic delivery representing the Subscriber’s Debenture and Warrants in accordance with the provisions hereof.

 

 
11

 

9.Subscriber’s Representations, Warranties & Acknowledgments. The Subscriber (on its own behalf and, if applicable, on behalf of each person on whose behalf the Subscriber is contracting) represents, warrants, covenants and acknowledges to the Corporation as follows and acknowledges that the Corporation and its counsel are relying on such representations, warranties and covenants in connection with the transactions contemplated in, and entry into by the Corporation of this Subscription Agreement, that both at the date hereof and at the Closing Time:

 

(a)The Subscriber (including, if applicable, each Disclosed Principal) was offered the Debenture Unit in, and is resident, or if not an individual has its head office in, the jurisdiction set out on the face page of this Subscription Agreement, and intends the applicable Securities Laws of that jurisdiction to govern the offer, sale and issuance of the Debenture and the Warrants to the Subscriber. Such address was not created and is not used solely for the purpose of acquiring the Debenture and the Warrants and the Subscriber was solicited to purchase in such jurisdiction. The Subscriber and any beneficial purchaser for whom it is acting was not created or used solely to purchase or hold the Debenture and the Warrants in reliance upon an exemption from the prospectus requirements as set out in NI 45-106.

 

(b)The Subscriber has properly completed, executed and delivered to the Corporation this Subscription Agreement and Schedule “A” – the United States Accredited Investor Representation Letter, including Appendix “1” to Schedule “A” – the Form of U.S. Accredited Investment Status Certificate, as applicable and the representations, warranties, covenants, and information contained herein and therein are true and correct as of the date hereof and will be true and correct as of the Closing.

 

(c)The Subscriber (including, if applicable, each Disclosed Principal) will not offer, sell or otherwise dispose of the Debenture, the underlying Common Shares, the Warrants, or the underlying Warrant Shares in the United States or to a U.S. Person unless such offer, sale or disposition is made in accordance with an exemption from the registration requirements under the U.S. Securities Act and the Securities Laws of all applicable states of the United States or the U.S. Securities and Exchange Commission has declared effective a registration statement in respect of such securities.

 

(d)The execution and delivery of this Subscription Agreement, the performance and compliance with the terms hereof, the subscription for the Debenture Unit and the completion of the transactions described herein by the Subscriber will not result in any material breach of, or be in conflict with, or constitute a material default under, or create a state of facts that, after notice or lapse of time, or both, would constitute a material default under any term or provision of the constating documents, by-laws or resolutions of the Subscriber (if applicable), the Securities Laws or any other laws applicable to the Subscriber, any agreement to which the Subscriber is a party, or any judgment, decree, order, statute, rule or regulation applicable to the Subscriber.

 

(e)The Subscriber is subscribing for the Debenture and the Warrants as principal for its own account and not for the benefit of any other person (within the meaning of all Applicable Securities Laws) or it is subscribing as agent for a Disclosed Principal, as disclosed on the face page of this Subscription Agreement, and acknowledges that the Corporation may be required by law to collect, use and disclose the Personal Information of the Subscriber (including, if applicable, any Disclosed Principal) and consents (including, if applicable, on behalf of any Disclosed Principal) to such collection, use and disclosure to certain regulatory authorities (including stock exchanges).

 

(f)In the case of a subscription for the Debenture and the Warrants by the Subscriber acting as trustee or agent for a fully managed account or as agent for a Disclosed Principal, the Subscriber is duly authorized to execute and deliver this Subscription Agreement and all other necessary documentation in connection with such subscription on behalf of the fully managed account or Disclosed Principal, as applicable, and this Subscription Agreement has been duly authorized, executed and delivered by or on behalf of and constitutes a legal, valid and binding agreement of, the fully managed account or Disclosed Principal, as applicable.

 

 
12

 

(g)In the case of a subscription for the Debenture Unit by the Subscriber acting as principal, this Subscription Agreement has been duly authorized, executed and delivered by, and constitutes a legal, valid and binding agreement of, the Subscriber. This Subscription Agreement is enforceable in accordance with its terms against the Subscriber.

 

(h)If the Subscriber is a corporation, the Subscriber is duly incorporated and is validly subsisting under the laws of its jurisdiction of incorporation and has all requisite legal and corporate power and authority to execute and deliver this Subscription Agreement, to subscribe for the Debenture and the Warrants as contemplated herein and to carry out and perform its obligations under the terms of this Subscription Agreement; a partnership, limited liability company, syndicate or other form of unincorporated organization, the Subscriber has the necessary legal capacity and authority to execute and deliver this Subscription Agreement and to observe and perform its covenants and obligations hereunder and has obtained all necessary approvals in respect thereof; or an individual, the Subscriber is of the full age of majority in the jurisdiction in which the Subscription agreement is executed and has all requisite legal capacity and competence to execute and deliver this Subscription Agreement and to observe and perform his or her covenants and obligations hereunder and, in any case, upon acceptance by the Corporation, this Subscription Agreement will constitute a legal, valid and binding agreement of the Subscriber enforceable against the Subscriber in accordance with its terms and will not result in a violation of, or create a state of facts which, after notice, lapse of time or both, would constitute a default or breach of, any of the Subscriber’s, constating documents, by-laws or authorizing resolutions (if applicable), any agreement to which the Subscriber, is a party or by which it is bound or any law applicable to the Subscriber, or any judgment, decree, order, statute, rule or regulation applicable to the Subscriber.

 

(i)There is no person acting or purporting to act in connection with the Offering who is entitled to any brokerage or finder’s fee. If any person establishes a claim that any fee or other compensation is payable in connection with this subscription for the Debenture and the Warrants, the Subscriber covenants to indemnify and hold harmless the Corporation with respect thereto and with respect to all costs reasonably incurred in the defence thereof.

 

(j)If required by Applicable Securities Laws or the Corporation, the Subscriber will execute, deliver and file, or assist the Corporation in filing, such reports, undertakings and other documents with respect to the issue and/or sale of the Debenture and the Warrants as may be required by any Securities Commission, stock exchange or other regulatory authority.

 

(k)The Subscriber (including, if applicable, each Disclosed Principal) has been advised to consult its own legal advisors with respect to trading in the Debenture, the Common Shares, the Warrants, and the underlying Warrant Shares, and with respect to the resale restrictions imposed by the Applicable Securities Laws of the jurisdiction in which the Subscriber resides and other Applicable Securities Laws, and acknowledges that no representation has been made respecting the applicable hold periods imposed by the Applicable Securities Laws or other resale restrictions applicable to such securities which restrict the ability of the Subscriber (or others for whom it is contracting hereunder) to resell such securities, that the Subscriber (including, if applicable, each Disclosed Principal) is solely responsible to find out what these restrictions are and the Subscriber is solely responsible (and the Corporation is not in any way responsible) for compliance with applicable resale restrictions and the Subscriber is aware that it (and, if applicable, each Disclosed Principal) may not be able to resell such Debenture, underlying Common Shares, Warrants, or underlying Warrant Shares except in accordance with limited exemptions under the Applicable Securities Laws and other applicable laws. The Subscriber also acknowledges the legend restriction notation applicable to the resale of the Debenture, the underlying Common Shares, the Warrants, and the underlying Warrant Shares, as set out below.

 

 
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  (l) The Subscriber (including, if applicable, each Disclosed Principal) has not received, nor has it requested, nor does it have any need to receive, a prospectus, registration statement or offering memorandum, within the meaning of the Securities Laws, or any sales or advertising literature in connection with the Offering or any document purporting to describe the business and affairs of the Corporation which has been prepared for review by prospective purchasers to assist in making an investment decision in respect of the Debenture and the Warrants, and the Subscriber’s decision to subscribe for the Debenture and the Warrants was not based upon, and the Subscriber has not relied upon, any verbal or written representations as to facts made by or on behalf of the Corporation. The Subscriber’s decision to subscribe for the Debenture and the Warrants was based solely upon this Subscription Agreement, including the Term Sheet, and information about the Corporation which is publicly available.
     
  (m) Except for its knowledge regarding its subscription for the Debenture and Warrants hereunder, the Subscriber has no knowledge of a “material fact” or a “material change” (as those terms are defined in the Securities Act (Ontario) and which generally means a fact or change which would reasonably be expected to have a significant effect on the market price of the Common Shares) in the affairs of the Corporation that has not been generally disclosed.
     
  (n) No person has made any written or oral representations:

 

  (i) that any person will resell or repurchase the Debenture, the underlying Common Shares, the Warrants or the underlying Warrant Shares,
     
  (ii) that any person will refund the Subscription Amount; or
     
  (iii) as to the future price or value of the Debenture, the underlying Common Shares, the Warrants or the underlying Warrant Shares.

 

  (o) The subscription for the Debenture and the Warrants has not been made through or as a result of, and the distribution of the Debentures and the Warrants is not being accompanied by any general solicitation or advertisement, including without limitation in printed public media, radio, television or telecommunications, including electronic display, or as part of a general solicitation.
     
  (p) There are risks associated with the purchase of and investment in the Debenture and the Warrants and the Subscriber has such knowledge and experience that it is capable of evaluating the merits and risks of an investment in the Debenture and the Warrants and fully understands the restrictions on resale of the Debenture, the underlying Common Shares, the Warrants, and the underlying Warrant Shares and is capable of bearing the economic risk of the investment.
     
  (q) The funds representing the Subscription Amount that will be advanced by the Subscriber to the Corporation hereunder will not represent proceeds of crime for the purposes of the Proceeds of Crime (Money Laundering) and Terrorist Financing Act (Canada) (the “PCMLTFA”) and the Subscriber acknowledges that the Corporation or its advisors may in the future be required by law to disclose the Subscriber’s name and other information relating to this Subscription Agreement and the Subscriber’s subscription hereunder, on a confidential basis, pursuant to the PCMLTFA. To the best of the Subscriber’s knowledge (a) none of the Subscription Amount to be provided by the Subscriber (i) has been or will be derived from or related to any activity that is deemed criminal under the law of Canada, the United States, or any other jurisdiction, or (ii) is being tendered on behalf of a person or entity who has not been identified to the Subscriber, and (b) the Subscriber shall promptly notify the Corporation if the Subscriber discovers that any of such representations ceases to be true, and to provide the Corporation with appropriate information in connection therewith. None of the funds the Subscriber is using to purchase the Debenture and Warrants are, to the knowledge of the Subscriber, proceeds obtained or derived, directly or indirectly, as a result of illegal activities.

 

 
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  (r) The Subscriber has not received from the Corporation any financial assistance of any kind, directly or indirectly, in connection with its purchase of the Debenture and Warrants hereunder.
     
  (s) The Subscriber (i) is not either an “insider” of the Corporation or a “registrant” (each as defined under Applicable Securities Laws) or, (ii) has identified itself to the Corporation as either an “insider” of the Corporation or a “registrant” (each as defined under Applicable Securities Laws).
     
  (t) The Subscriber has accurately disclosed on the cover page of this Subscription Agreement, their ownership, directly or indirectly, of any securities of the Corporation as of the date of this Subscription Agreement, including, but not limited to, their direct or indirect ownership of Common Shares, Warrants, Debentures and options of the Corporation.
     
  (u) Legal counsel retained by the Corporation is acting as counsel to the Corporation and not as counsel to the Purchaser and the Purchaser may not rely upon such counsel in any respect. The Purchaser should obtain independent legal advice with respect to the investment in the Debenture Unit.

 

10. Acknowledgements and Covenants of the Subscriber. The Subscriber, on its own behalf and, if applicable on behalf of others for whom it is acting hereunder, hereby acknowledges, covenants and agrees as follows:

 

  (a) It has received and reviewed a copy of the Term Sheet setting out the principal terms of the Offering.
     
  (b) No Securities Commission, agency, governmental authority, regulatory body, stock exchange or other regulatory body or similar regulatory authority has reviewed or passed on the merits of the Debenture and the Warrants.
     
  (c) The Subscriber acknowledges that the Debenture, the underlying Common Shares, the Warrants and the underlying Warrant Shares have not been, and will not be, registered under the U.S. Securities Act and may not be offered or sold in the United States or to a U.S. Person unless the Debenture, the underlying Common Shares, the Warrants and the underlying Warrant Shares are registered under the U.S. Securities Act and all applicable state Securities Laws or an exemption from such registration requirements is available, and further agrees that hedging transactions involving such Common Shares may not be conducted unless in compliance with the U.S. Securities Act.
     
  (d) The Debenture, the underlying Common Shares, the Warrants and the underlying Warrant Shares shall be subject to statutory resale restrictions under the Applicable Securities Laws of the jurisdiction in which the Subscriber resides and under other Applicable Securities Laws, and the Subscriber covenants that it will not resell the Debenture, the underlying Common Shares, the Warrants, or the underlying Warrant Shares except in compliance with such laws and the Subscriber acknowledges that it is solely responsible for such compliance.

 

 
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  (e) The ability to transfer the Debenture, the underlying Common Shares, the Warrants, and the underlying Warrant Shares is limited by, among other things, Applicable Securities Laws and the Corporation shall refuse, and shall instruct its transfer agent to refuse to register any transfer that does not comply with the Applicable Securities Laws. It is the responsibility of the Subscriber to find out what the transfer restrictions are and to comply with them before selling their securities.
     
  (f) None of the Corporation or any of its officers, directors, employees, shareholders, representatives, affiliates, related entities and associates, or any persons acting on its or their behalf, will in any circumstances be liable to the Subscriber under, arising out of, or in any way connected with this Subscription Agreement for any indirect or consequential loss or damage whether arising in contract or tort.
     
  (g) The Debenture, the underlying Common Shares, the Warrants, and the underlying Warrant Shares shall have attached to them, as of the Closing Date, the legends substantially in the following form and with the necessary information inserted:

 

“UNLESS PERMITTED UNDER SECURITIES LEGISLATION, THE HOLDER OF THIS SECURITY MUST NOT TRADE THE SECURITY BEFORE MARCH 14, 2021”

 

“THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “U.S. SECURITIES ACT”) OR U.S. STATE SECURITIES LAWS. THESE SECURITIES MAY BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED, DIRECTLY OR INDIRECTLY, ONLY (A) TO BRIACELL THERAPEUTICS CORP. (THE “CORPORATION”), (B) OUTSIDE THE UNITED STATES IN COMPLIANCE WITH RULE 904 OF REGULATION S UNDER THE U.S. SECURITIES ACT AND IN COMPLIANCE WITH APPLICABLE LOCAL LAWS AND REGULATIONS, (C) IN COMPLIANCE WITH THE EXEMPTION FROM THE REGISTRATION REQUIREMENTS UNDER THE U.S. SECURITIES ACT PROVIDED BY (I) RULE 144 THEREUNDER IF AVAILABLE OR (II) RULE 144A THEREUNDER, IF AVAILABLE, AND IN EACH CASE IN ACCORDANCE WITH APPLICABLE U.S. STATE SECURITIES LAWS, (D) IN ANOTHER TRANSACTION THAT DOES NOT REQUIRE REGISTRATION UNDER THE U.S. SECURITIES ACT OR ANY APPLICABLE STATE SECURITIES LAWS, OR (E) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE U.S. SECURITIES ACT, PROVIDED THAT, IN THE CASE OF TRANSFERS PURSUANT TO (C)(I) OR (D) ABOVE, THE HOLDER HAS, PRIOR TO SUCH TRANSFER, FURNISHED TO THE CORPORATION AN OPINION OF COUNSEL OR OTHER EVIDENCE OF EXEMPTION, IN EITHER CASE REASONABLY SATISFACTORY TO THE CORPORATION. DELIVERY OF THIS CERTIFICATE MAY NOT CONSTITUTE “GOOD DELIVERY” IN SETTLEMENT OF TRANSACTIONS ON STOCK EXCHANGES IN CANADA.”

 

and if required:

 

 
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“WITHOUT PRIOR WRITTEN APPROVAL OF THE TSX VENTURE EXCHANGE AND COMPLIANCE WITH ALL APPLICABLE SECURITIES LEGISLATION, THE SECURITIES REPRESENTED BY THIS CERTIFICATE MAY NOT BE SOLD, TRANSFERRED, HYPOTHECATED OR OTHERWISE TRADED ON OR THROUGH THE FACILITIES OF THE TSX VENTURE EXCHANGE OR OTHERWISE IN CANADA OR TO OR FOR THE BENEFIT OF A CANADIAN RESIDENT MARCH 14, 2021. ”

 

  (h) The Subscriber, and each Disclosed Principal, if applicable, shall execute, deliver, file and otherwise assist the Corporation with filing all documentation required by the applicable Securities Laws to permit the subscription for the Debenture and Warrants and the issuance of the Debenture and the Warrants and the listing of the underlying Common Shares and Warrant Shares on the TSX Venture Exchange.
     
  (i) The Corporation is relying on an exemption from the requirement to provide the Subscriber with a prospectus under applicable Securities Laws and, as a consequence of acquiring the Debenture and the Warrants pursuant to such exemption:

 

  (i) certain protections, rights and remedies provided by applicable Securities Laws, including statutory rights of rescission and certain statutory remedies against an issuer, underwriters, auditors, directors and officers that are available to investors who acquire securities offered by a prospectus, will not be available to the Subscriber,
     
  (ii) the common law may not provide investors with an adequate remedy in the event that they suffer investment losses in connection with securities acquired in a private placement,
     
  (iii) the Subscriber may not receive information that would otherwise be required to be given under applicable Securities Laws, and
     
  (iv) the Corporation is relieved from certain obligations that would otherwise apply under applicable Securities Laws.

 

  (j) The Subscriber is responsible for obtaining such legal and tax advice as it considers appropriate in connection with the execution, delivery and performance of this Subscription Agreement and the transactions contemplated under this Subscription Agreement, and the Subscriber is not relying on the Corporation or its affiliates or counsel, in this regard.
     
  (k) There is no government guarantee or insurance covering the Debenture and the Warrants.
     
  (l) There are risks associated with the purchase of the Debenture and the Warrants and the Subscriber may lose his, her or its entire investment.
     
  (m) This Subscription Agreement and the Schedules hereto require the Subscriber to provide certain Personal Information to the Corporation. Such information is being collected by the Corporation for the purposes of completing the Offering, which includes, without limitation, determining the Subscriber’s eligibility to purchase the Debenture and the Warrants under the Securities Laws and other applicable laws, preparing and registering such securities to be issued to the Subscriber and completing filings required by any stock exchange, securities regulatory authority or taxation authority. The Subscriber’s Personal Information may be disclosed by the Corporation and its advisors to: (a) stock exchanges or securities regulatory authorities, (b) the Corporation’s registrar and transfer agent; (c) the Canada Revenue Agency, and (d) any of the other parties involved in the Offering, including legal counsel and may be included in record books in connection with the Offering. By executing this Subscription Agreement, the Subscriber is deemed to be consenting to the foregoing collection, use and disclosure of the Subscriber’s Personal Information. The Subscriber also consents to the filing of copies or originals of this Subscription Agreement (including all Schedules) and any other document relating to the Offering as may be required to be filed with any stock exchange, securities regulatory authority or taxation authority in connection with the transactions contemplated hereby. The Subscriber represents and warrants that it has the authority to provide the consents and acknowledgements set out in this paragraph on behalf of each Disclosed Principal, as applicable.

 

 
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  (n) The Subscriber hereby acknowledges and consents to the collection, use, and disclosure of certain Personal Information by the British Columbia Securities Commission, including the publishing or otherwise making available to the public, Personal Information including, for individuals, their name, number and type of securities purchased, the purchase price therefor, and their insider or registrant status, if applicable, and for non-individual Subscribers, the above information and their address, contact person name and telephone number and the exemption that the Subscriber is relying on in purchasing the Debenture and the Warrants. In the event the Subscriber has any questions with respect to the indirect collection of such information, the Subscriber should contact the British Columbia Securities Commission, P.O. Box 10142, Pacific Centre, 701 West Georgia Street, Vancouver, British Columbia V7Y 1L2, Telephone: 1-800-373-6393, Facsimile: (604) 899-6581, E-mail: inquiries@bcsc.bc.ca.
     
  (o) The Subscriber is not a “control person” of the Corporation, as that term is defined in the Securities Act (British Columbia), will not become a “control person” of the Corporation by purchasing the Debenture and the number of Warrants subscribed for under this Subscription Agreement, and does not intend to act jointly or in concert with any other person to form a control group in respect of the Corporation. The Subscriber has not and will not enter into any voting trust or similar agreement that has the effect of directing the manner in which the votes attached to the securities purchased pursuant to this Subscription Agreement may be voted following the Closing Date.
     
  (p) The Subscriber will not resell the Debenture, the underlying Common Shares (if applicable), the Warrants, or the underlying Warrant Shares (if applicable) except in accordance with the provisions of Applicable Securities Laws and stock exchange rules, if applicable, in the future.
     
  (q) The Subscriber acknowledges that the Corporation may complete additional financings in the future in order to develop the proposed business of the Corporation and to fund its ongoing development; that there is no assurance that such financings will be available and, if available, on reasonable terms; any such future financings may have a dilutive effect on current securityholders, including the Subscriber; that if such future financings are not available, the Corporation may be unable to fund its ongoing development and the lack of capital resources may result in the failure of its business venture.
     
  (r) The Subscriber acknowledges and agrees that, other than as set forth in the Term Sheet, all costs incurred by the Subscriber (including any fees and disbursements of any special counsel retained by the Subscriber) relating to the sale of the Debenture and Warrants to the Subscriber shall be borne by the Subscriber.

 

 
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  (s) The Subscriber acknowledges that all warranties, conditions, representations or stipulations, whether express or implied and whether arising hereunder or under prior agreement or statement or by statute or at common law, are expressly those of the Corporation. The Subscriber acknowledges that no information or representation concerning the Corporation has been provided to the Subscriber by the Corporation other than those contained in this Subscription Agreement, and that the Subscriber is relying entirely upon this Subscription Agreement for any representations or warranties in relation to the Corporation.

 

11. Reliance on Representations, Warranties, Covenants and Acknowledgements. The Subscriber acknowledges and agrees that the representations, warranties, covenants and acknowledgements made by the Subscriber in this Subscription Agreement are made with the intention that they may be relied upon by the Corporation and its counsel in determining the Subscriber’s eligibility (and, if applicable, the eligibility of others for whom the Subscriber is contracting hereunder) to purchase the Debenture and the Warrants under Securities Laws. The Subscriber undertakes to immediately notify the Corporation of any change in any statement or other information relating to the Subscriber set forth in this Subscription Agreement that takes place prior to the Closing time. The Subscriber further agrees that by accepting the Debenture and the Warrants, the Subscriber shall be representing and warranting that such representations, warranties, acknowledgements and covenants are true as at the Closing Time with the same force and effect as if they had been made by the Subscriber at the Closing Time.
   
12. Survival of Representations, Warranties and Covenants of the Subscriber. The representations, warranties and covenants of the Subscriber contained in this Subscription Agreement and any certificate or document delivered pursuant to or in connection with this Subscription Agreement shall survive the Closing and, notwithstanding such Closing or any investigation made by or on behalf of the Corporation with respect thereto, and notwithstanding any subsequent disposition by the Subscriber of the Debenture, the underlying Common Shares, the Warrants, or the underlying Warrant Shares, and shall continue in full force and effect for the benefit of the Corporation for a period of two years following the Closing Date.
   
13. General Authorization to Correct Minor Errors. The Subscriber hereby authorizes the Corporation and its counsel to correct any minor errors in, or complete any minor information missing from any part of the Subscription Agreement and any other acknowledgements, provisions, forms, certificates or documents executed by the Subscriber and delivered to the Corporation in connection with the Offering.
   
14. No Regulatory Endorsement. The Subscriber is aware that no stock exchange or governmental agency, authority, regulatory body, Securities Commission or other entity has made any finding or determination as to the merit of investment in, nor has any such stock exchange or governmental agency, authority, regulatory body, Securities Commission, or other entity made any recommendation or endorsement with respect to the Debenture or Warrants.
   
15. Legal and Tax Advice. The Subscriber acknowledges and agrees that it is solely responsible for obtaining such legal advice and tax advice as it considers appropriate in connection with the execution, delivery and performance by it of this Subscription Agreement and the completion of the transactions contemplated hereby.
   
16. No Revocation. The Subscriber, on its own behalf and, if applicable, on the behalf of others for whom it is contracting hereunder, agrees that this offer is made for valuable consideration and may not be withdrawn, cancelled, terminated or revoked by the Subscriber on its own behalf and, if applicable, on behalf of others for whom it is contracting hereunder, without the consent of the Corporation.

 

 
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17. Indemnity. The Subscriber agrees to indemnify and hold harmless the Corporation and its directors, officers, employees, agents, advisers and shareholders from and against any and all loss, liability, claim, damage and expense whatsoever (including, but not limited to, any and all fees, costs and expenses whatsoever reasonably incurred in investigating, preparing or defending against any claim, law suit, administrative proceeding or investigation whether commenced or threatened) arising out of or based upon any representation or warranty of the Subscriber contained herein or in any document furnished by the Subscriber to the Corporation in connection herewith being untrue in any material respect or any breach or failure by the Subscriber to comply with any covenant or agreement made by the Subscriber herein or in any document furnished by the Subscriber to the Corporation in connection herewith. The Subscriber represents and warrants that it has the authority to provide the consents and acknowledgements set out in this paragraph on behalf of all beneficial purchasers.
   
18. Assignment. The terms and provisions of this Subscription Agreement shall be binding upon and enure to the benefit of the Subscriber, the Corporation and their respective successors and assigns; provided that, except for the assignment by a Subscriber who is acting as nominee or agent to the beneficial owner and as otherwise herein provided, this Subscription Agreement shall not be assignable by any party without the prior written consent of the other parties.
   
19. Governing Law. This Subscription Agreement shall be governed by and construed in accordance with the laws of the Province of Ontario and the federal laws of Canada applicable therein. The Subscriber on its own behalf and, if applicable, on behalf of others for whom it is contracting hereunder, hereby irrevocably attorns to the jurisdiction of the courts of the Province of Ontario with respect to any matters arising out of this Subscription Agreement.
   
20. Facsimile Subscriptions and Counterparts. The Corporation shall be entitled to rely on electronic delivery or delivery by facsimile machine of an executed copy of this Subscription Agreement, including the completed schedules hereto, and acceptance by the Corporation of such electronic or facsimile copy shall be legally effective to create a valid and binding agreement between the Subscriber and the Corporation in accordance with the terms hereof. This Subscription Agreement may be executed in any number of counterparts, each of which when delivered, either in original, electronic or facsimile form, shall be deemed to be an original and all of which together shall constitute one and the same document.
   
21. Entire Agreement and Modification. This Subscription Agreement (including the schedules hereto) contains the entire agreement of the parties hereto relating to the subject matter hereof and there are no representations, covenants or other agreements relating to the subject matter hereof except as stated or referred to herein. Subject to the terms hereof, neither this Subscription Agreement nor any provision hereof shall be modified, changed, discharged or terminated except by an instrument in writing signed by the party against whom any waiver, change, discharge or termination is sought.
   
22. Headings. The division of this Subscription Agreement into Articles, Sections, Schedules and other subdivisions and the inclusion of headings are for convenience of reference only and shall not affect the construction or interpretation of this Subscription Agreement. The headings in this Subscription Agreement are not intended to be full or precise descriptions of the text to which they refer. Unless something in the subject matter or context is inconsistent therewith, references herein to an Article, Section, Subsection, paragraph, clause or Schedule are to the applicable article, section, subsection, paragraph, clause or schedule of this Subscription Agreement.
   
23. Time of Essence. Time is of the essence of this Subscription Agreement.
   
24. Effective Date. This Subscription Agreement is intended to and shall take effect on the Closing Date, notwithstanding its actual date of execution or delivery by any of the parties.
   
25. Currency. Except if specifically stated otherwise, all dollar amounts herein are in Canadian dollars.
   
26. Gender and Number. Words importing the singular number only shall include the plural and vice versa, and words importing the masculine gender shall include the feminine gender and vice versa.
   
27. Severability. If any one or more of the provisions contained in this Subscription Agreement should be invalid, illegal or unenforceable in any respect in any jurisdiction, the validity, legality and enforceability of such provision or provisions shall not in any way be affected or impaired thereby in any other jurisdiction and the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless in either case as a result of such determination this Subscription Agreement would fail of its essential purpose.
   
28. Language. The parties hereto acknowledge and confirm that they have requested that this Subscription Agreement as well as all notices and other documents contemplated hereby be drawn up in the English language

 

 
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SCHEDULE “A”

United States Accredited

Investor Representation Letter

 

This United States Accredited Investor Representation Letter is being delivered in connection with the execution and delivery of the Subscription Agreement of the undersigned purchaser (the “Purchaser”) in connection with the issuance of a debenture (the “Debenture”) of BriaCell Therapeutics Corp. (the “Corporation”). Capitalized terms used herein and not defined herein will have the meanings ascribed thereto in the Subscription Agreement. The Purchaser represents, warrants and covenants (which representations, warranties and covenants will survive the Closing Date) on its own behalf and, if applicable, on behalf of any beneficial purchaser for whom the Purchaser is contracting hereunder to the Corporation and acknowledges that the Corporation and its respective counsel are relying thereon that:

 

  (a) The Purchaser understands and acknowledges that the Debenture has not been and will not be registered under the U.S. Securities Act or the securities laws of any state of the United States, and that the offer and sale of the Debentures to it are being made in reliance upon the exemption from registration provided by Regulation D under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) and similar exemptions under applicable state securities laws.
     
  (a) The Purchaser is an “accredited investor” as defined in Rule 501(a) of Regulation D under the U.S. Securities Act (a “U.S. Accredited Investor”) and has executed and delivered to the Corporation Appendix “1” and, if applicable, Appendix “2”, to this Schedule “A” and is acquiring the Debenture for its own account and not on behalf of any other person or for the account of a U.S. Accredited Investor with respect to which it exercises sole investment discretion and, in either case, not with a view to any resale, distribution or other disposition of the Debenture in violation of United States federal or state securities laws.
     
  (b) The Purchaser acknowledges that it has not purchased the Debenture as a result of any “directed selling efforts” (as defined in Regulation S under the U.S. Securities Act (“Regulation S”) or any “general solicitation” or “general advertising” (as those terms are used in Regulation D under the U.S. Securities Act), including advertisements, articles, notices or other communications published in any newspaper, magazine or similar media or on the Internet, or broadcast over radio or television, or the internet, or any seminar or meeting whose attendees have been invited by general solicitation or general advertising.
     
  (c) The Purchaser understands and acknowledges that the Debenture will be “restricted securities” within the meaning of Rule 144(a)(3) under the U.S. Securities Act, and agrees that if it decides to offer, sell, pledge or otherwise transfer any of the Debenture, it will not offer, sell, pledge or otherwise transfer any of such securities, directly or indirectly, unless the transfer is:

 

    (i) to the Corporation, or a subsidiary thereof (though the Corporation or its subsidiaries are under no obligation to purchase any such Debenture);
       
    (ii) made outside the United States in accordance with Rule 904 of Regulation S and in compliance with applicable local laws and regulations;

 

 
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    (iii) made in compliance with the exemption from registration under the U.S. Securities Act provided by Rule 144 under the U.S. Securities Act, if available or Rule 144A under the U.S. Securities Act, if available;
       
    (iv) in another transaction that does not require registration under the U.S. Securities Act, and the holder of the Debenture has furnished to the Corporation an opinion of counsel of recognized standing in form and substance reasonably satisfactory to the Corporation to such effect; or
       
    (v) pursuant to an effective registration statement under the U.S. Securities Act, and in each case in compliance with any applicable state securities laws in the United States;

 

  (d) Upon the original issuance of the Debenture and until such time as is no longer required under applicable requirements of the U.S. Securities Act or applicable state securities laws, all certificates representing the Debenture sold in the United States to Accredited Investors, and all certificates issued in exchange therefor or in substitution thereof, shall bear a legend substantially in the following form:

 

“THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “U.S. SECURITIES ACT”) OR U.S. STATE SECURITIES LAWS. THESE SECURITIES MAY BE OFFERED, SOLD, PLEDGED OR OTHERWISE TRANSFERRED, DIRECTLY OR INDIRECTLY, ONLY (A) TO BRIACELL THERAPEUTICS CORP. (THE “CORPORATION”), (B) OUTSIDE THE UNITED STATES IN COMPLIANCE WITH RULE 904 OF REGULATION S UNDER THE U.S. SECURITIES ACT AND IN COMPLIANCE WITH APPLICABLE LOCAL LAWS AND REGULATIONS, (C) IN COMPLIANCE WITH THE EXEMPTION FROM THE REGISTRATION REQUIREMENTS UNDER THE U.S. SECURITIES ACT PROVIDED BY (I) RULE 144 THEREUNDER IF AVAILABLE OR (II) RULE 144A THEREUNDER, IF AVAILABLE, AND IN EACH CASE IN ACCORDANCE WITH APPLICABLE U.S. STATE SECURITIES LAWS, (D) IN ANOTHER TRANSACTION THAT DOES NOT REQUIRE REGISTRATION UNDER THE U.S. SECURITIES ACT OR ANY APPLICABLE STATE SECURITIES LAWS, OR (E) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE U.S. SECURITIES ACT, PROVIDED THAT, IN THE CASE OF TRANSFERS PURSUANT TO (C)(I) OR (D) ABOVE, THE HOLDER HAS, PRIOR TO SUCH TRANSFER, FURNISHED TO THE CORPORATION AN OPINION OF COUNSEL OR OTHER EVIDENCE OF EXEMPTION, IN EITHER CASE REASONABLY SATISFACTORY TO THE CORPORATION. DELIVERY OF THIS CERTIFICATE MAY NOT CONSTITUTE “GOOD DELIVERY” IN SETTLEMENT OF TRANSACTIONS ON STOCK EXCHANGES IN CANADA.”

 

 
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provided, that if, the Debenture are being sold in compliance with the requirements of Rule 904 of Regulation S and in compliance with applicable local laws and regulations, the above legend may be removed by providing a declaration to the Corporation and to the transfer agent for the Corporation, in the form attached as Schedule “B” to this Subscription Agreement (or as the Corporation may prescribe from time to time); provided further, if any of the Debenture are being sold pursuant to Rule 144 under the U.S. Securities Act, if available, the legend may be removed by delivering to the Corporation and the transfer agent for the Corporation an opinion of counsel of recognized standing in form and substance reasonably satisfactory to the Corporation, to the effect that the legend is no longer required under applicable requirements of the U.S. Securities Act.

 

Notwithstanding the foregoing, the transfer agent for the Corporation may impose additional requirements for the removal of legends from securities sold in compliance with Rule 904 of Regulation S in the future;

 

  (e) The Purchaser consents to the Corporation making a notation on its records or giving instructions to any transfer agent of the Debenture in order to implement the restrictions on transfer set forth and described herein;
     
  (f) If required by applicable securities legislation, regulatory policy or order or by any securities commission, stock exchange or other regulatory authority, the Purchaser will execute, deliver, file and otherwise assist the Corporation in filing reports, questionnaires, undertakings and other documents with respect to the ownership of the Debenture;
     
  (g) The Purchaser acknowledges that neither the Corporation nor any person representing the Corporation has made any representation to it with respect to the Corporation or the offering or sale of the Debenture, other than the information contained or incorporated by reference in this Subscription Agreement, which has been delivered to it and upon which it is relying in making its investment decision with respect to the Debenture;
     
  (h) The Purchaser understands that the Corporation is not obligated to file and has no present intention of filing with the U.S. Securities and Exchange Commission or with any state securities administrator any registration statement in respect of resales of the Debenture in the United States, and acknowledges that there are substantial restrictions on the transferability of the Debenture and that it may not be possible for the Purchaser to readily liquidate his, her or its investment in the case of an emergency at any time;
     
  (i) The Purchaser understands and agrees that the financial statements of the Corporation have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board, and are subject to Canadian auditing and auditor independence standards, which differ in some respects from United States generally accepted accounting principles, and United States auditing and auditor independence standards, respectively, and thus may not be comparable to financial statements of United States companies;
     
  (j) The Purchaser understands and agrees that there may be material tax consequences to it of an acquisition, holding, exercise or disposition of the Debenture. The Corporation gives no opinion and makes no representation with respect to the tax consequences to the Purchaser under United States, state, local or foreign tax law of its acquisition, holding, exercise or disposition of the Debenture, and the Purchaser acknowledges that it is solely responsible for determining the tax consequences to it with respect to its investment, including whether the Corporation will at any given time be deemed a “passive foreign investment company” within the meaning of Section 1297 of the United States Internal Revenue Code of 1986, as amended;

 

 
23

 

  (k) The Purchaser is aware that its ability to enforce civil liabilities under the United States federal securities laws may be affected adversely by, among other things: (i) the fact that the Corporation is organized under the laws of Ontario, Canada; (ii) some or all of the directors and officers may be residents of countries other than the United States; and (iii) all or a substantial portion of the assets of the Corporation and such persons may be located outside the United States;
     
  (l) The office or other address of the Purchaser at which the Purchaser received and accepted the offer to purchase the Debenture is the address listed as the Purchaser’s Residential Address” on the face page of the Subscription Agreement;
     
  (m) That the funds representing the Subscription Price which will be advanced by the Purchaser to the Corporation, hereunder will not represent proceeds of crime for the purposes of the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act (the “PATRIOT Act”) and the Purchaser acknowledges that the Corporation may in the future be required by law to disclose the Purchaser’s name and other information relating to the subscription agreement and the Purchaser’s subscription hereunder, on a confidential basis, pursuant to the PATRIOT Act. No portion of the Aggregate Subscription Price to be provided by the Purchaser (i) has been or will be derived from or related to any activity that is deemed criminal under the laws of the United States, or any other jurisdiction, or (ii) is being tendered on behalf of a person or entity who has not been identified to or by the Purchaser, and it shall promptly notify the Corporation if the Purchaser discovers that any of such representations ceases to be true and provide the Corporation with appropriate information in connection therewith; and
     
  (n) The provisions of this United States Accredited Investor Representation Letter will be true and correct both as of the date of execution of this Subscription Agreement and as of the Closing Date.

 

The Purchaser undertakes to notify the Corporation immediately of any change in any representation, warranty or other information relating to the Purchaser or, if applicable, the beneficial purchaser set forth herein, which takes place prior to the Closing Date.

 

DATED at __________________________ this ___ day of _______________, 2020.
   
   
Name of Entity  
   
   
Type of Entity  
   
   
Signature of Person Signing  
   
   
Print or Type Name and Title of Person Signing  
   

 

 
24

 

APPENDIX 1 TO SCHEDULE “A”

FORM OF U.S. ACCREDITED INVESTOR CERTIFICATE

 

In connection with the purchase of a Debenture of BriaCell Therapeutics Corp. (the “Corporation”) by the undersigned, as an integral part of the accompanying Subscription Agreement, the undersigned hereby represents and warrants to the Corporation that the undersigned, and each beneficial purchaser, if any, on whose behalf the undersigned is subscribing for the Debenture, satisfies one or more of the following accredited investor categories, within the meaning of Rule 501(a) of Regulation D under the U.S. Securities Act (please write “PUR” for the undersigned Purchaser, and “BP” for each beneficial purchaser, if any, on each line that applies):

 

  _______Category 1. A bank, as defined in Section 3(a)(2) of the U.S. Securities Act, whether acting in its individual or fiduciary capacity; a savings and loan association or other institution as defined in Section 3(a)(5)(A) of the U.S. Securities Act, whether acting in its individual or fiduciary capacity; a broker or dealer registered pursuant to Section 15 of the United States Securities Exchange Act of 1934, as amended; an insurance company as defined in Section 2(a)(13) of the U.S. Securities Act; an investment company registered under the United States Investment Company Act of 1940, as amended; a business development company as defined in Section 2(a)(48) of the United States Investment Company Act of 1940, as amended; a small business investment company licensed by the U.S. Small Business Administration under Section 301 (c) or (d) of the United States Small Business Investment Act of 1958, as amended; a plan established and maintained by a state, its political subdivisions or any agency or instrumentality of a state or its political subdivisions, for the benefit of its employees, with total assets in excess of US$5,000,000; or an employee benefit plan within the meaning of the United States Employee Retirement Income Security Act of 1974, as amended, in which the investment decision is made by a plan fiduciary, as defined in Section 3(21) of such Act, which is either a bank, savings and loan association, insurance company or registered investment adviser, or an employee benefit plan with total assets in excess of US$5,000,000 or, if a self-directed plan, with investment decisions made solely by persons who are “accredited investors” (as such term is defined in Rule 501(a) of Regulation D under the U.S. Securities Act); or
     
  _______ Category 2. A private business development company as defined in Section 202(a)(22) of the United States Investment Advisers Act of 1940, as amended; or
     
  _______ Category 3. An organization described in Section 501(c)(3) of the United States Internal Revenue Code of 1986, as amended, a corporation, a Massachusetts or similar business trust, a limited liability company or a partnership, not formed for the specific purpose of acquiring the Debenture offered, with total assets in excess of US$5,000,000; or
     
  _______ Category 4. A director or executive officer of the Corporation; or
     
  _______ Category 5. A natural person with individual “net worth”, or joint “net worth” with his or her spouse, at the time of purchase in excess of US$1,000,000;

 

 
25

 

Note: For purposes of calculating “net worth” under this paragraph:

 

(i) The person’s primary residence shall not be included as an asset;

 

(ii) Indebtedness that is secured by the person’s primary residence, up to the estimated fair market value of the primary residence at the time of the sale of securities, shall not be included as a liability (except that if the amount of such indebtedness outstanding at the time of the sale of the Debenture exceeds the amount outstanding 60 days before such time, other than as a result of the acquisition of the primary residence, the amount of such excess shall be included as a liability); and

 

(iii) Indebtedness that is secured by the person’s primary residence in excess of the estimated fair market value of the primary residence at the time of the sale of the Debenture shall be included as a liability; or

 

  _______ Category 6. A natural person who had an individual income in excess of US$200,000 in each of the last two years or joint income with his or her spouse in excess of US$300,000 in each of those years, and who reasonably expects to reach the same income level in the current year; or
     
  _______ Category 7. A trust, with total assets in excess of US$5,000,000, not formed for the specific purpose of acquiring the Debenture, whose purchase is directed by a sophisticated person as described in Rule 506(b)(2)(ii) under the U.S. Securities Act.
     
  _______ Category 8. An entity in which all of the equity owners are Accredited Investors.

 

The Purchaser acknowledges that if it is an individual U.S. Accredited Investor that is relying on the net worth or income eligibility qualifications set forth in Category 5 or Category 6 above, such Purchaser shall also complete and deliver to the Corporation a U.S. Individual Accredited Investor Questionnaire in the form attached as Appendix 2 to this Schedule “A”.

 

Terms used herein but not otherwise defined have the meaning ascribed hereto in the accompanying Subscription Agreement.

 

  Dated: ____________________   Signed: ________________________________
       
       
     

Print the Name of Purchaser

       
       
     

Print Name and Title of Authorized Signing Officer

 

 
26

 

APPENDIX 2 TO SCHEDULE “A”

 

U.S. INDIVIDUAL ACCREDITED INVESTOR QUESTIONNAIRE

 

I understand that in order to be accepted as an “accredited investor”, I must satisfy certain of the following standards. The undersigned hereby represents and warrants to BriaCell Therapeutics Corp. (the “Corporation”) as follows:

 

GENERAL INFORMATION REQUIRED OF EACH PROSPECTIVE INVESTOR:

 

1. General Information

 

Name(s): _______________________   _______________________
       
Principal Residence: _______________________    _______________________
       
  _______________________   _______________________
       
  _______________________   _______________________
       
Business Hours Telephone:  _______________________   _______________________
       
Home Telephone:  _______________________   _______________________
       
Email: _______________________   _______________________

 

2. Financial Status. Please answer the following questions concerning your financial status by marking the appropriate box and filling in the blanks.

 

2.1 Does your individual or joint (together with your spouse) net worth exceed US$1,000,000? For the purpose of calculating your individual or joint (together with your spouse) net worth, (i) your primary residence shall not be included as an asset, (ii) indebtedness that is secured by your primary residence, up to the estimated fair market value of the primary residence as of the date hereof, shall not be included as a liability (except that if the amount of such indebtedness outstanding as of the date hereof exceeds the amount outstanding 60 days before the date hereof, other than as a result of the acquisition of the primary residence, the amount of such excess shall be included as a liability) and (iii) indebtedness that is secured by your primary residence in excess of the estimated fair market value of your primary residence as of the date hereof shall be included as a liability:

 

  [  ]  Yes   [  ] No

 

2.1.1 If you answered “No” to Question 2.1, please indicate the actual amount of individual or joint (together with your spouse) net worth (calculated in accordance with the instructions provided in Question 2.1 above).

 

US$ ______________

 

2.2 Please indicate, for each of the two most recent years, what your individual income (or joint income together with your spouse) was, and for the current year what your individual income (or joint income together with your spouse) is expected to be.

 

 
27

 

  2017 Individual ____________________   Joint  ____________________
           
  2018 Individual ____________________   Joint  ____________________
           
  2020 Individual ____________________   Joint ______________________

 

3. Financial Background. Please respond to the following questions, supplying as much detail as possible in order to make your answers complete.

 

3.1 Indicate by check mark which of the following categories best describes the extent of your prior experience in the areas of investment listed below:

 

No Experience   Some Experience   Substantial Experience
         
[  ]   [  ]   [  ] Marketable Securities
         
[  ]   [  ]   [  ] Securities for which no public market exists

 

3.2 For those investments for which you indicated “Substantial Experience” or “Some Experience” in question 3.1 above, please answer the following additional question:

 

How often do you make your own investment decisions with respect to such investments?

 

3.3 Do you have adequate means of providing for your current needs and personal contingencies and have no need for liquidity in such investments?

 

  [  ]  Yes   [  ] No

 

4. Prior Purchases of Securities. Have you made prior purchases of securities sold in reliance on the private offering exemption from registration under the U.S. Securities Act:

 

  [  ]  Yes   [  ] No

 

I hereby represent and warrant that:

 

(a) I, individually or together with my spouse, have a net worth (i.e., a total assets in excess of total liabilities, as calculated in accordance with the instructions provided in Question 2.1 above) of at least US$1,000,000; or

 

(b) I, individually (without my spouse), have had an income of not less than US$200,000 (or, jointly with my spouse, US$300,000) during each of the last two years, and reasonably expect that I will have an income of at least US$200,000 (or US$300,000, together with my spouse) during the present year.

 

The foregoing representations and warranties and all other information which I have provided to the Corporation concerning myself and my financial condition are true and accurate as of the date hereof. If in any respect, such representations, warranties, or information shall not be true and accurate, I will give written notice of such fact to the Corporation specifying which representations, warranties or information are not true and accurate, and the reasons therefor.

 

I understand that the information contained herein is being furnished by me in order for the Corporation to determine my suitability as an “accredited investor”, may be accepted by the Corporation in light of the requirements of Regulation D under the U.S. Securities Act and that the Corporation will rely on the information contained herein for purposes of such determination.

 

IN WITNESS WHEREOF, the undersigned has executed this U.S. Individual Accredited Investor Questionnaire as of the________day of _______________________, 2020.

 

   
Print or Type Name  
   
X ______________________________________________  
Signature  

 

 

 

 

SCHEDULE “B”`

 

FORM OF DECLARATION FOR REMOVAL OF U.S. LEGEND

 

TO: BriaCell Therapeutics Corp. (and any transfer agent for BriaCell Therapeutics Corp.)

 

The undersigned (a) acknowledges that the sale of _____________________ Debenture of BriaCell Therapeutics Corp. (the “Issuer”) to which this declaration relates, represented by certificate number ______________, is being made in reliance on Rule 904 of Regulation S under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), and (b) certifies that (1) it is not an “affiliate” (as defined in Rule 405 under the U.S. Securities Act) of the Issuer, (2) the offer of such securities was not made to a person in the United States, and either (A) at the time the buy order was originated, the buyer was outside the United States, or the seller and any person acting on its behalf reasonably believe that the buyer was outside the United States, or (B) the transaction was executed on or through the facilities of the Canadian Securities Exchange (or another designated offshore securities market) and neither the seller nor any person acting on its behalf knows that the transaction has been prearranged with a buyer in the United States, (3) neither the seller nor any affiliate of the seller nor any person acting on any of their behalf has engaged or will engage in any “directed selling efforts” in the United States in connection with the offer and sale of such securities, (4) the sale is bona fide and not for the purpose of “washing off” the resale restrictions imposed because the securities are “restricted securities” (as such term is defined in Rule 144(a)(3) under the U.S. Securities Act), (5) the seller does not intend to replace the securities sold in reliance on Rule 904 of Regulation S under the U.S. Securities Act with fungible unrestricted securities, and (6) the contemplated sale is not a transaction, or part of a series of transactions which, although in technical compliance with Regulation S under the U.S. Securities Act, is part of a plan or scheme to evade the registration provisions of the U.S. Securities Act. Terms used herein have the meanings given to them by Regulation S under the U.S. Securities Act.

 

Dated: ___________    
 

By:

 
  Signature  
   
 

Print name of Signatory

(if different from Purchaser)

   
  Title

 

 

 

 

SCHEDULE C
NON-INDIVIDUAL SUBSCRIBERS

 

Complete this Schedule C for non-individual Subscribers if the Subscriber, (i) is a member of the “Pro Group” (as described below), or (ii) is (or will be after completion of the Offering) an “Insider” (as described below), or (iii) will be a holder of more than 5% of the common shares of the Corporation after completion of the Offering and assuming conversion of the Debenture and exercise of the Warrants.

 

A Registration Form
   
The Subscriber either [check appropriate box]:
 
[  ] has previously filed with the TSX Venture Exchange (the “TSXV”) a Form 4C, Corporate Placee Registration Form, represents and warrants that there has been no change to any of the information in the Corporate Placee Registration Form previously filed with the TSXV up to the date hereof; or
   
[  ] hereby delivers a completed Form 4C, Corporate Placee Registration Form, in the form attached as Appendix A to this Schedule C to the Corporation for filing with the TSXV.
   
B. Insider Status
   
The Subscriber either [check appropriate box]:
 
[  ] is an “Insider” of the Corporation as defined in the policies of the TSXV as follows:
   
  (a) a director or senior officer of the Corporation;
     
  (b) a director or senior officer of a company that is itself an Insider or subsidiary of the Corporation;
     
  (c) a person that beneficially owns or controls, directly or indirectly, voting shares of the Corporation carrying more than 10% of the voting rights attached to all the Corporation’s outstanding voting shares; or
     
  (d) the Corporation itself if it holds any of its own securities; or
     
[  ] is not an Insider of the Corporation.

 

 

 

 

C. Member of “Pro Group”
   
The Subscriber either [check appropriate box]:
 
[  ] is a member of the “Pro Group” as defined in the Rules of the TSXV, as follows:

 

  1 subject to subparagraphs (2), (3) and (4), either individually or as a group:

 

  (a) the member (i.e. a member of the TSXV under TSXV requirements);
     
  (b) employees of the member;
     
  (c) partners, officers or directors of the member;
     
  (d) affiliates of the member; and
     
  (e) associates of any parties referred to in subparagraphs (a) through (d);

 

  2. the TSXV may, in its discretion, include a person or party in the Pro Group for the purposes of a particular calculation where the TSXV determines that the person is not acting at arm’s length with the member;
     
  3. the TSXV may, in its discretion, exclude a person from the Pro Group for the purposes of a particular calculation where the TSXV determines that the person is acting at arm’s length with the member;
     
  4.

the member may deem a person who would otherwise be included in the Pro Group pursuant to subparagraph (1) to be excluded from the Pro Group where the member determines that:

 

 

  (a) the person is an affiliate or associate of the member acting at arm’s length of the member;
     
  (b) the associate or affiliate has a separate corporate and reporting structure;
     
  (c) there are sufficient controls on information flowing between the member and the associate or affiliate; and
     
  (d) the member maintains a list of such excluded persons; or

 

[  ] is not a member of the Pro Group.

 

 

 

 

appendix a to schedule C

 

 

 


TSX VENTURE EXCHANGE
PRIVATE PLACEMENT FORM

 

FORM 4C
CORPORATE PLACEE REGISTRATION FORM

 

This Form will remain on file with the Exchange and must be completed if required under section 4(b) of Part II of Form 4B. The corporation, trust, portfolio manager or other entity (the “Placee”) need only file it on one time basis, and it will be referenced for all subsequent Private Placements in which it participates. If any of the information provided in this Form changes, the Placee must notify the Exchange prior to participating in further placements with Exchange listed Issuers. If as a result of the Private Placement, the Placee becomes an Insider of the Corporation, Insiders of the Placee are reminded that they must file a Personal Information Form (2A) or, if applicable, Declarations, with the Exchange.

 

1. Placee Information:

 

  (a) Name: ______________________________________________________________________
     
  (b) Complete Address: ____________________________________________________________
     
  (c) Jurisdiction of Incorporation or Creation: ____________________________________________

 

2. (a) Is the Placee purchasing securities as a portfolio manager: (Yes/No)? _______________________

 

  (b)

Is the Placee carrying on business as a portfolio manager outside of Canada:

(Yes/No)?____________________________________________________________________

 

3. If the answer to 2(b) above was “Yes”, the undersigned certifies that:

 

  (a) it is purchasing securities of the Corporation on behalf of managed accounts for which it is making the investment decision to purchase the securities and has full discretion to purchase or sell securities for such accounts without requiring the client’s express consent to a transaction;
     
  (b) it carries on the business of managing the investment portfolios of clients through discretionary authority granted by those clients (a “portfolio manager” business) in ____________________ [jurisdiction], and it is permitted by law to carry on a portfolio manager business in that jurisdiction;
     
  (c) it was not created solely or primarily for the purpose of purchasing securities of the Corporation;
     
  (d) the total asset value of the investment portfolios it manages on behalf of clients is not less than $20,000,000; and
     
  (e) it has no reasonable grounds to believe, that any of the directors, senior officers and other insiders of the Corporation, and the persons that carry on investor relations activities for the Corporation has a beneficial interest in any of the managed accounts for which it is purchasing.

 

 

 

 

4. If the answer to 2(a). above was “No”, please provide the names and addresses of Control Persons of the Placee:

 

Name *   City   Province or State   Country
             
             
             
             

 

* If the Control Person is not an individual, provide the name of the individual that makes the investment decisions on behalf of the Control Person.

 

5.Acknowledgement - Personal Information and Securities Laws

 

(a)Personal Information” means any information about an identifiable individual, and includes information contained in sections 1, 2 and 4, as applicable, of this Form.

 

The undersigned hereby acknowledges and agrees that it has obtained the express written consent of each individual to:

 

(i)the disclosure of Personal Information by the undersigned to the Exchange (as defined in Appendix 6B) pursuant to this Form; and

 

(ii)the collection, use and disclosure of Personal Information by the Exchange for the purposes described in Appendix 6B or as otherwise identified by the Exchange, from time to time.

 

(b)The undersigned acknowledges that it is bound by the provisions of applicable Securities Law, including provisions concerning the filing of insider reports and reports of acquisitions.

 

Dated and certified (if applicable), acknowledged and agreed, at _____________________________________________on ____________________________________.

 

   
  (Name of Purchaser - please print)
   
   
  (Authorized Signature)
   
   
  (Official Capacity - please print)
   
   
  (Please print name of individual whose signature
  appears above)

 

THIS IS NOT A PUBLIC DOCUMENT

 

 

 

 

SCHEDULE D

 

TERM SHEET

 

(See attached)

 

 

 

 

SCHEDULE E

 

DEBENTURE CERTIFICATE

 

(See attached)

 

 

 

 

EX-23.1 8 ex23-1.htm

 

Exhibit 23.1

 

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

We consent to the reference to our firm under the caption “Experts and Legal Matters” and to the use of our report dated November 30, relating to the consolidated financial statements of BriaCell Therapeutics Corp. in the Registration Statement (Form F-1) and the related Prospectus of BriaCell Therapeutics Corp. dated December 10, 2020.

 

December 10, 2020

/s/ MNP LLP
  Chartered Professional Accountants
Mississauga, Canada Licensed Public Accountants

 

 

 

 

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